Sutter Bipolar Forceps-Calvian
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Sutter FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Bipolar Forceps EUDAMEDBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.4mm 45° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, straight, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.0 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, US 22cm, straight, tip 2.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.5 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.0 x 3.0mm according to Dr.Teo FDA UDIBipolar forceps SuperGliss®, US 22cm, straight, tip 1.5 x 8.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 24cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 14.5cm, bayonet, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss® zhora, US 18cm, bayonet, tip 0.4 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 26cm, bayonet, tip 0.7 x 8.0mm angled up FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.2 x 8.0mm FDA UDIBipolar forceps SuperGliss® zhora, US 23cm, bayonet, tip 0.4 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss® zhora, US 18cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.5 x 8.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 17.5cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.2 x 8.0mm 45° angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.2 x 8.0mm 45° angled up FDA UDIBipolar forceps SuperGliss®, US 14.5cm, bayonet, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 25cm, straight, tip 2.0 x 8.0mm 30° angled down FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.4mm 80°angled up FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 1.0 x 3.0mm according to Dr.Teo FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 1.0 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 1.2 x 8.0mm 45° angled down FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 2.0 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, ELP, US 24cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4mm 45°angled down FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 2.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 26cm, bayonet, tip 1.2 x 8.0mm angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 17cm, tip 2.0 x 8.0mm type Meuser FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 0.5 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.7 x 8.0mm 45° angled up FDA UDIBipolar forceps SuperGliss®, US 25cm, straight, tip 1.0 x 8.0mm 30° angled down FDA UDIBipolar forceps SuperGliss® zhora, US 14.5cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 16cm, bayonet, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 1.5 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss® zhora, US 18cm, bayonet, tip 1.0 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, straight, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 11cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.7 x 8.0mm 45° angled down FDA UDIBipolar forceps SuperGliss® zhora, US 14.5cm, bayonet, tip 0.2 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 2.0 x 3.0mm acc. to Dr.Teo, 60° and 10mm angled up FDA UDIBipolar forceps SuperGliss® zhora, US 23cm, bayonet, tip 1.0 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4mm 80° angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 1.0 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4mm 45° angled upd FDA UDIBipolar forceps SuperGliss® zhora, US 20cm, bayonet, tip 0.2 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 11cm, straight, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss® zhora, US 19cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 17.5cm, straight, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss® zhora, US 23cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 26cm, bayonet, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 1.0 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 27cm, straight, tip 2.5 x 8.0mm FDA UDI
- Model / Reference
- 782286SLS EUDAMEDFDA UDI780179SGS EUDAMEDFDA UDI783051SGS EUDAMEDFDA UDI780272SGS EUDAMEDFDA UDI783191SGS EUDAMEDFDA UDI782151SGS EUDAMEDFDA UDI783275SGS EUDAMEDFDA UDI780271SGS EUDAMEDFDA UDI780291SLS EUDAMEDFDA UDI780449SGS EUDAMEDFDA UDI784954SGSZ EUDAMEDFDA UDI780394SGS EUDAMEDFDA UDI780292SGS EUDAMEDFDA UDI784994SGSZ EUDAMEDFDA UDI780171SGS EUDAMEDFDA UDI784957SGSZ EUDAMEDFDA UDI782180SGS EUDAMEDFDA UDI780191SLS EUDAMEDFDA UDI782183SLS EUDAMEDFDA UDI780151SGS EUDAMEDFDA UDI780291SGS EUDAMEDFDA UDI782154SGS EUDAMEDFDA UDI782288SGS EUDAMEDFDA UDI780169SLS EUDAMEDFDA UDI780295SGS EUDAMEDFDA UDI780148SGS EUDAMEDFDA UDI780276SGS EUDAMEDFDA UDI782181SGS EUDAMEDFDA UDI782386SLS EUDAMEDFDA UDI783192SGS EUDAMEDFDA UDI782189SLS EUDAMEDFDA UDI780198SLS EUDAMEDFDA UDI780197SGS EUDAMEDFDA UDI783193SGS EUDAMEDFDA UDI780299SLS EUDAMEDFDA UDI782297SLS EUDAMEDFDA UDI782182SGS EUDAMEDFDA UDI780395SGS EUDAMEDFDA UDI780199SLS EUDAMEDFDA UDI780178SGS EUDAMEDFDA UDI780499SGS EUDAMEDFDA UDI783052SGS EUDAMEDFDA UDI780194SGS EUDAMEDFDA UDI780275SGS EUDAMEDFDA UDI784947SGSZ EUDAMEDFDA UDI782454SGS EUDAMEDFDA UDI780469SGS EUDAMEDFDA UDI783153SGS EUDAMEDFDA UDI784950SGSZ EUDAMEDFDA UDI780172SGS EUDAMEDFDA UDI780199SGS EUDAMEDFDA UDI780243SGS EUDAMEDFDA UDI780196SGS EUDAMEDFDA UDI784946SGSZ EUDAMEDFDA UDI783197SGS EUDAMEDFDA UDI784990SGSZ EUDAMEDFDA UDI782396SLS EUDAMEDFDA UDI780167SLS EUDAMEDFDA UDI782296SLS EUDAMEDFDA UDI784976SGSZ EUDAMEDFDA UDI780437SGS EUDAMEDFDA UDI784987SGSZ EUDAMEDFDA UDI780154SGS EUDAMEDFDA UDI784997SGSZ EUDAMEDFDA UDI780399SGS EUDAMEDFDA UDI782181SLS EUDAMEDFDA UDI780168SLS EUDAMEDFDA UDI782152SGS EUDAMEDFDA UDI780298SGS EUDAMEDFDA UDI780281SGS EUDAMEDFDA UDI700292 EUDAMED780148SG EUDAMED700178 EUDAMED782286SL EUDAMED700291SV3 EUDAMED782454SG EUDAMED784954SGZ EUDAMEDE700382 EUDAMED780206SG EUDAMED780295SG EUDAMED700219 EUDAMED780272SG EUDAMED787889 EUDAMED702287 EUDAMED784964SGZ EUDAMEDE700150 EUDAMED780199SL EUDAMED700281 EUDAMED782386SL EUDAMED700152 EUDAMED789989 EUDAMED700346 EUDAMEDE700349 EUDAMED700190 EUDAMED782288SG EUDAMED700199 EUDAMED700176 EUDAMED700156 EUDAMED700299 EUDAMED700864 EUDAMEDE700182 EUDAMED780284SG EUDAMED780237SG EUDAMEDE700161 EUDAMED780196SG EUDAMEDE700241 EUDAMED780695SG EUDAMED700376 EUDAMED780795SG EUDAMED700209 EUDAMED700283 EUDAMED700196 EUDAMED700155 EUDAMEDE700180 EUDAMED789687 EUDAMEDE700204 EUDAMED700291 EUDAMED782387SL EUDAMED784976SGZ EUDAMED780692SG EUDAMED700865 EUDAMED780281SG EUDAMED780392SG EUDAMED780437SG EUDAMED780168SG EUDAMED700290 EUDAMED784984SGZ EUDAMED782296SL EUDAMED780191SG EUDAMEDE700175 EUDAMED784996SGZ EUDAMED780179SG EUDAMED780395SG EUDAMEDE700290 EUDAMED782181SG EUDAMED788189 EUDAMED700214 EUDAMED783051SG EUDAMED784956SGZ EUDAMED782489SG EUDAMED780238SG EUDAMED787989 EUDAMED700860 EUDAMED700158 EUDAMED702285 EUDAMED700295 EUDAMED700180 EUDAMED780291SL EUDAMED700176SV2 EUDAMED780168SL EUDAMED780381SG EUDAMEDE700170 EUDAMED700151 EUDAMED780193SG EUDAMED700206 EUDAMED700184 EUDAMEDE700284 EUDAMED702181 EUDAMED780454SG EUDAMED780194SG EUDAMED784997SGZ EUDAMED780167SL EUDAMEDE700240 EUDAMED780479SG EUDAMED788687 EUDAMED702180 EUDAMED782151SG EUDAMEDE700158 EUDAMED700175 EUDAMED700287 EUDAMEDE700160 EUDAMED700248 EUDAMED782152SG EUDAMED700246 EUDAMED700192 EUDAMED783153SG EUDAMED780499SL EUDAMED700245 EUDAMEDE700214 EUDAMED702182 EUDAMEDE700376 EUDAMED780198SL EUDAMED700204F EUDAMEDE700195 EUDAMEDE700194 EUDAMED780298SL EUDAMED700331 EUDAMED702189 EUDAMED700222 EUDAMED783192SG EUDAMED782182SG EUDAMED780154SG EUDAMED780499SG EUDAMEDE700209 EUDAMED782297SL EUDAMED782585SL EUDAMED780291SG EUDAMED780239SG EUDAMED780293SG EUDAMED780294SG EUDAMED700194 EUDAMED780298SG EUDAMED784967SGZ EUDAMED700150 EUDAMED700181 EUDAMED782184SG EUDAMEDE700155 EUDAMED700826 EUDAMED780797SG EUDAMEDE700166 EUDAMED782287SL EUDAMED784980SGZ EUDAMED700244 EUDAMED702284 EUDAMED700892 EUDAMED780271SG EUDAMED782181SL EUDAMEDE700285 EUDAMED783253SG EUDAMED783052SG EUDAMED700881 EUDAMEDE700181 EUDAMED780243SG EUDAMED700871 EUDAMED780160SG EUDAMED700166 EUDAMED787788 EUDAMED700179 EUDAMED700204 EUDAMED700189 EUDAMED788788 EUDAMEDE700190 EUDAMED700182 EUDAMED700824 EUDAMED780175SG EUDAMEDE700292 EUDAMED700161 EUDAMED700825 EUDAMED700294 EUDAMED780197SG EUDAMED780183SG EUDAMED780449SG EUDAMEDE700242 EUDAMEDE700185 EUDAMED702288 EUDAMED783196SG EUDAMED782157SG EUDAMED780296SG EUDAMEDE700270 EUDAMED783276SG EUDAMED784950SGZ EUDAMED780198SG EUDAMED780599SG EUDAMED700270 EUDAMEDE700191 EUDAMEDE700219 EUDAMED782397SL EUDAMED
- Description
- Bipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.4mm 45° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, straight, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.0 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, US 22cm, straight, tip 2.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.5 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.0 x 3.0mm according to Dr.Teo FDA UDIBipolar forceps SuperGliss®, US 22cm, straight, tip 1.5 x 8.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 24cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 14.5cm, bayonet, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss® zhora, US 18cm, bayonet, tip 0.4 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 26cm, bayonet, tip 0.7 x 8.0mm angled up FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.2 x 8.0mm FDA UDIBipolar forceps SuperGliss® zhora, US 23cm, bayonet, tip 0.4 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss® zhora, US 18cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.5 x 8.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 17.5cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.2 x 8.0mm 45° angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.2 x 8.0mm 45° angled up FDA UDIBipolar forceps SuperGliss®, US 14.5cm, bayonet, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 25cm, straight, tip 2.0 x 8.0mm 30° angled down FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.4mm 80°angled up FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 1.0 x 3.0mm according to Dr.Teo FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 1.0 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 1.2 x 8.0mm 45° angled down FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 2.0 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, ELP, US 24cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4mm 45°angled down FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 2.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 26cm, bayonet, tip 1.2 x 8.0mm angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 17cm, tip 2.0 x 8.0mm type Meuser FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 19cm, bayonet, tip 0.5 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.7 x 8.0mm 45° angled up FDA UDIBipolar forceps SuperGliss®, US 25cm, straight, tip 1.0 x 8.0mm 30° angled down FDA UDIBipolar forceps SuperGliss® zhora, US 14.5cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 16cm, bayonet, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 1.5 x 3.0mm according to Dr. Teo FDA UDIBipolar forceps SuperGliss® zhora, US 18cm, bayonet, tip 1.0 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 19cm, straight, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 11cm, straight, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 0.7 x 8.0mm 45° angled down FDA UDIBipolar forceps SuperGliss® zhora, US 14.5cm, bayonet, tip 0.2 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 22cm, bayonet, tip 2.0 x 3.0mm acc. to Dr.Teo, 60° and 10mm angled up FDA UDIBipolar forceps SuperGliss® zhora, US 23cm, bayonet, tip 1.0 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4mm 80° angled up FDA UDIBipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 1.0 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 22cm, bayonet, tip 0.4mm 45° angled upd FDA UDIBipolar forceps SuperGliss® zhora, US 20cm, bayonet, tip 0.2 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 11cm, straight, tip 0.2 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss® zhora, US 19cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 17.5cm, straight, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss® zhora, US 23cm, bayonet, tip 0.7 x 5.0mm 10° angled up FDA UDIBipolar forceps SuperGliss®, US 26cm, bayonet, tip 0.4 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, ELP, US 19cm, bayonet, tip 1.0 x 6.0mm FDA UDIBipolar forceps SuperGliss®, ELP, US 16cm, bayonet, tip 0.7 x 6.0mm FDA UDIBipolar forceps SuperGliss®, US 15.5cm, straight, tip 0.7 x 8.0mm MicroTip FDA UDIBipolar forceps SuperGliss®, US 24cm, bayonet, tip 1.0 x 8.0mm FDA UDIBipolar forceps SuperGliss®, US 27cm, straight, tip 2.5 x 8.0mm FDA UDI
Identifiers
- Catalog Number
- 782286SLS FDA UDI780179SGS FDA UDI783051SGS FDA UDI780272SGS FDA UDI783191SGS FDA UDI782151SGS FDA UDI783275SGS FDA UDI780271SGS FDA UDI780291SLS FDA UDI780449SGS FDA UDI784954SGSZ FDA UDI780394SGS FDA UDI780292SGS FDA UDI784994SGSZ FDA UDI780171SGS FDA UDI784957SGSZ FDA UDI782180SGS FDA UDI780191SLS FDA UDI782183SLS FDA UDI780151SGS FDA UDI780291SGS FDA UDI782154SGS FDA UDI782288SGS FDA UDI780169SLS FDA UDI780295SGS FDA UDI780148SGS FDA UDI780276SGS FDA UDI782181SGS FDA UDI782386SLS FDA UDI783192SGS FDA UDI782189SLS FDA UDI780198SLS FDA UDI780197SGS FDA UDI783193SGS FDA UDI780299SLS FDA UDI782297SLS FDA UDI782182SGS FDA UDI780395SGS FDA UDI780199SLS FDA UDI780178SGS FDA UDI780499SGS FDA UDI783052SGS FDA UDI780194SGS FDA UDI780275SGS FDA UDI784947SGSZ FDA UDI782454SGS FDA UDI780469SGS FDA UDI783153SGS FDA UDI784950SGSZ FDA UDI780172SGS FDA UDI780199SGS FDA UDI780243SGS FDA UDI780196SGS FDA UDI784946SGSZ FDA UDI783197SGS FDA UDI784990SGSZ FDA UDI782396SLS FDA UDI780167SLS FDA UDI782296SLS FDA UDI784976SGSZ FDA UDI780437SGS FDA UDI784987SGSZ FDA UDI780154SGS FDA UDI784997SGSZ FDA UDI780399SGS FDA UDI782181SLS FDA UDI780168SLS FDA UDI782152SGS FDA UDI780298SGS FDA UDI780281SGS FDA UDI
- Primary DI / UDI-DI
- ESUM782286SLS0 EUDAMEDFDA UDIESUM780179SGS0 EUDAMEDFDA UDIESUM783051SGS0 EUDAMEDFDA UDIESUM780272SGS0 EUDAMEDFDA UDIESUM783191SGS0 EUDAMEDFDA UDIESUM782151SGS0 EUDAMEDFDA UDIESUM783275SGS0 EUDAMEDFDA UDIESUM780271SGS0 EUDAMEDFDA UDIESUM780291SLS0 EUDAMEDFDA UDIESUM780449SGS0 EUDAMEDFDA UDIESUM784954SGSZ0 EUDAMEDFDA UDIESUM780394SGS0 EUDAMEDFDA UDIESUM780292SGS0 EUDAMEDFDA UDIESUM784994SGSZ0 EUDAMEDFDA UDIESUM780171SGS0 EUDAMEDFDA UDIESUM784957SGSZ0 EUDAMEDFDA UDIESUM782180SGS0 EUDAMEDFDA UDIESUM780191SLS0 EUDAMEDFDA UDIESUM782183SLS0 EUDAMEDFDA UDIESUM780151SGS0 EUDAMEDFDA UDIESUM780291SGS0 EUDAMEDFDA UDIESUM782154SGS0 EUDAMEDFDA UDIESUM782288SGS0 EUDAMEDFDA UDIESUM780169SLS0 EUDAMEDFDA UDIESUM780295SGS0 EUDAMEDFDA UDIESUM780148SGS0 EUDAMEDFDA UDIESUM780276SGS0 EUDAMEDFDA UDIESUM782181SGS0 EUDAMEDFDA UDIESUM782386SLS0 EUDAMEDFDA UDIESUM783192SGS0 EUDAMEDFDA UDIESUM782189SLS0 EUDAMEDFDA UDIESUM780198SLS0 EUDAMEDFDA UDIESUM780197SGS0 EUDAMEDFDA UDIESUM783193SGS0 EUDAMEDFDA UDIESUM780299SLS0 EUDAMEDFDA UDIESUM782297SLS0 EUDAMEDFDA UDIESUM782182SGS0 EUDAMEDFDA UDIESUM780395SGS0 EUDAMEDFDA UDIESUM780199SLS0 EUDAMEDFDA UDIESUM780178SGS0 EUDAMEDFDA UDIESUM780499SGS0 EUDAMEDFDA UDIESUM783052SGS0 EUDAMEDFDA UDIESUM780194SGS0 EUDAMEDFDA UDIESUM780275SGS0 EUDAMEDFDA UDIESUM784947SGSZ0 EUDAMEDFDA UDIESUM782454SGS0 EUDAMEDFDA UDIESUM780469SGS0 EUDAMEDFDA UDIESUM783153SGS0 EUDAMEDFDA UDIESUM784950SGSZ0 EUDAMEDFDA UDIESUM780172SGS0 EUDAMEDFDA UDIESUM780199SGS0 EUDAMEDFDA UDIESUM780243SGS0 EUDAMEDFDA UDIESUM780196SGS0 EUDAMEDFDA UDIESUM784946SGSZ0 EUDAMEDFDA UDIESUM783197SGS0 EUDAMEDFDA UDIESUM784990SGSZ0 EUDAMEDFDA UDIESUM782396SLS0 EUDAMEDFDA UDIESUM780167SLS0 EUDAMEDFDA UDIESUM782296SLS0 EUDAMEDFDA UDIESUM784976SGSZ0 EUDAMEDFDA UDIESUM780437SGS0 EUDAMEDFDA UDIESUM784987SGSZ0 EUDAMEDFDA UDIESUM780154SGS0 EUDAMEDFDA UDIESUM784997SGSZ0 EUDAMEDFDA UDIESUM780399SGS0 EUDAMEDFDA UDIESUM782181SLS0 EUDAMEDFDA UDIESUM780168SLS0 EUDAMEDFDA UDIESUM782152SGS0 EUDAMEDFDA UDIESUM780298SGS0 EUDAMEDFDA UDIESUM780281SGS0 EUDAMEDFDA UDIESUM7002920 EUDAMEDESUM780148SG0 EUDAMEDESUM7001780 EUDAMEDESUM782286SL0 EUDAMEDESUM700291SV30 EUDAMEDESUM782454SG0 EUDAMEDESUM784954SGZ0 EUDAMEDESUME7003820 EUDAMEDESUM780206SG0 EUDAMEDESUM780295SG0 EUDAMEDESUM7002190 EUDAMEDESUM780272SG0 EUDAMEDESUM7878890 EUDAMEDESUM7022870 EUDAMEDESUM784964SGZ0 EUDAMEDESUME7001500 EUDAMEDESUM780199SL0 EUDAMEDESUM7002810 EUDAMEDESUM782386SL0 EUDAMEDESUM7001520 EUDAMEDESUM7899890 EUDAMEDESUM7003460 EUDAMEDESUME7003490 EUDAMEDESUM7001900 EUDAMEDESUM782288SG0 EUDAMEDESUM7001990 EUDAMEDESUM7001760 EUDAMEDESUM7001560 EUDAMEDESUM7002990 EUDAMEDESUM7008640 EUDAMEDESUME7001820 EUDAMEDESUM780284SG0 EUDAMEDESUM780237SG0 EUDAMEDESUME7001610 EUDAMEDESUM780196SG0 EUDAMEDESUME7002410 EUDAMEDESUM780695SG0 EUDAMEDESUM7003760 EUDAMEDESUM780795SG0 EUDAMEDESUM7002090 EUDAMEDESUM7002830 EUDAMEDESUM7001960 EUDAMEDESUM7001550 EUDAMEDESUME7001800 EUDAMEDESUM7896870 EUDAMEDESUME7002040 EUDAMEDESUM7002910 EUDAMEDESUM782387SL0 EUDAMEDESUM784976SGZ0 EUDAMEDESUM780692SG0 EUDAMEDESUM7008650 EUDAMEDESUM780281SG0 EUDAMEDESUM780392SG0 EUDAMEDESUM780437SG0 EUDAMEDESUM780168SG0 EUDAMEDESUM7002900 EUDAMEDESUM784984SGZ0 EUDAMEDESUM782296SL0 EUDAMEDESUM780191SG0 EUDAMEDESUME7001750 EUDAMEDESUM784996SGZ0 EUDAMEDESUM780179SG0 EUDAMEDESUM780395SG0 EUDAMEDESUME7002900 EUDAMEDESUM782181SG0 EUDAMEDESUM7881890 EUDAMEDESUM7002140 EUDAMEDESUM783051SG0 EUDAMEDESUM784956SGZ0 EUDAMEDESUM782489SG0 EUDAMEDESUM780238SG0 EUDAMEDESUM7879890 EUDAMEDESUM7008600 EUDAMEDESUM7001580 EUDAMEDESUM7022850 EUDAMEDESUM7002950 EUDAMEDESUM7001800 EUDAMEDESUM780291SL0 EUDAMEDESUM700176SV20 EUDAMEDESUM780168SL0 EUDAMEDESUM780381SG0 EUDAMEDESUME7001700 EUDAMEDESUM7001510 EUDAMEDESUM780193SG0 EUDAMEDESUM7002060 EUDAMEDESUM7001840 EUDAMEDESUME7002840 EUDAMEDESUM7021810 EUDAMEDESUM780454SG0 EUDAMEDESUM780194SG0 EUDAMEDESUM784997SGZ0 EUDAMEDESUM780167SL0 EUDAMEDESUME7002400 EUDAMEDESUM780479SG0 EUDAMEDESUM7886870 EUDAMEDESUM7021800 EUDAMEDESUM782151SG0 EUDAMEDESUME7001580 EUDAMEDESUM7001750 EUDAMEDESUM7002870 EUDAMEDESUME7001600 EUDAMEDESUM7002480 EUDAMEDESUM782152SG0 EUDAMEDESUM7002460 EUDAMEDESUM7001920 EUDAMEDESUM783153SG0 EUDAMEDESUM780499SL0 EUDAMEDESUM7002450 EUDAMEDESUME7002140 EUDAMEDESUM7021820 EUDAMEDESUME7003760 EUDAMEDESUM780198SL0 EUDAMEDESUM700204F0 EUDAMEDESUME7001950 EUDAMEDESUME7001940 EUDAMEDESUM780298SL0 EUDAMEDESUM7003310 EUDAMEDESUM7021890 EUDAMEDESUM7002220 EUDAMEDESUM783192SG0 EUDAMEDESUM782182SG0 EUDAMEDESUM780154SG0 EUDAMEDESUM780499SG0 EUDAMEDESUME7002090 EUDAMEDESUM782297SL0 EUDAMEDESUM782585SL0 EUDAMEDESUM780291SG0 EUDAMEDESUM780239SG0 EUDAMEDESUM780293SG0 EUDAMEDESUM780294SG0 EUDAMEDESUM7001940 EUDAMEDESUM780298SG0 EUDAMEDESUM784967SGZ0 EUDAMEDESUM7001500 EUDAMEDESUM7001810 EUDAMEDESUM782184SG0 EUDAMEDESUME7001550 EUDAMEDESUM7008260 EUDAMEDESUM780797SG0 EUDAMEDESUME7001660 EUDAMEDESUM782287SL0 EUDAMEDESUM784980SGZ0 EUDAMEDESUM7002440 EUDAMEDESUM7022840 EUDAMEDESUM7008920 EUDAMEDESUM780271SG0 EUDAMEDESUM782181SL0 EUDAMEDESUME7002850 EUDAMEDESUM783253SG0 EUDAMEDESUM783052SG0 EUDAMEDESUM7008810 EUDAMEDESUME7001810 EUDAMEDESUM780243SG0 EUDAMEDESUM7008710 EUDAMEDESUM780160SG0 EUDAMEDESUM7001660 EUDAMEDESUM7877880 EUDAMEDESUM7001790 EUDAMEDESUM7002040 EUDAMEDESUM7001890 EUDAMEDESUM7887880 EUDAMEDESUME7001900 EUDAMEDESUM7001820 EUDAMEDESUM7008240 EUDAMEDESUM780175SG0 EUDAMEDESUME7002920 EUDAMEDESUM7001610 EUDAMEDESUM7008250 EUDAMEDESUM7002940 EUDAMEDESUM780197SG0 EUDAMEDESUM780183SG0 EUDAMEDESUM780449SG0 EUDAMEDESUME7002420 EUDAMEDESUME7001850 EUDAMEDESUM7022880 EUDAMEDESUM783196SG0 EUDAMEDESUM782157SG0 EUDAMEDESUM780296SG0 EUDAMEDESUME7002700 EUDAMEDESUM783276SG0 EUDAMEDESUM784950SGZ0 EUDAMEDESUM780198SG0 EUDAMEDESUM780599SG0 EUDAMEDESUM7002700 EUDAMEDESUME7001910 EUDAMEDESUME7002190 EUDAMEDESUM782397SL0 EUDAMED
- Basic UDI-DI
- ++ESUMTD02700000AL EUDAMED
- Direct Marketing DI
- ESUM783192SGS0 EUDAMEDESUM7002920 EUDAMEDESUM780148SG0 EUDAMEDESUM7001780 EUDAMEDESUM782286SL0 EUDAMEDESUM780276SGS0 EUDAMEDESUM782151SGS0 EUDAMEDESUM700291SV30 EUDAMEDESUM782454SG0 EUDAMEDESUM784954SGZ0 EUDAMEDESUM780243SGS0 EUDAMEDESUME7003820 EUDAMEDESUM780206SG0 EUDAMEDESUM780295SG0 EUDAMEDESUM7002190 EUDAMEDESUM780272SG0 EUDAMEDESUM7878890 EUDAMEDESUM780148SGS0 EUDAMEDESUM780199SLS0 EUDAMEDESUM783191SGS0 EUDAMEDESUM7022870 EUDAMEDESUM784964SGZ0 EUDAMEDESUM780281SGS0 EUDAMEDESUM780197SGS0 EUDAMEDESUM780198SLS0 EUDAMEDESUME7001500 EUDAMEDESUM780167SLS0 EUDAMEDESUM780199SL0 EUDAMEDESUM7002810 EUDAMEDESUM784976SGSZ0 EUDAMEDESUM782386SL0 EUDAMEDESUM7001520 EUDAMEDESUM782152SGS0 EUDAMEDESUM782386SLS0 EUDAMEDESUM780299SLS0 EUDAMEDESUM7899890 EUDAMEDESUM7003460 EUDAMEDESUM782396SLS0 EUDAMEDESUM780199SGS0 EUDAMEDESUME7003490 EUDAMEDESUM7001900 EUDAMEDESUM782288SG0 EUDAMEDESUM7001990 EUDAMEDESUM7001760 EUDAMEDESUM7001560 EUDAMEDESUM7002990 EUDAMEDESUM7008640 EUDAMEDESUME7001820 EUDAMEDESUM780284SG0 EUDAMEDESUM782181SGS0 EUDAMEDESUM780237SG0 EUDAMEDESUM780275SGS0 EUDAMEDESUME7001610 EUDAMEDESUM780196SG0 EUDAMEDESUM780169SLS0 EUDAMEDESUME7002410 EUDAMEDESUM780695SG0 EUDAMEDESUM7003760 EUDAMEDESUM780795SG0 EUDAMEDESUM7002090 EUDAMEDESUM7002830 EUDAMEDESUM780395SGS0 EUDAMEDESUM7001960 EUDAMEDESUM7001550 EUDAMEDESUME7001800 EUDAMEDESUM7896870 EUDAMEDESUME7002040 EUDAMEDESUM780292SGS0 EUDAMEDESUM7002910 EUDAMEDESUM782387SL0 EUDAMEDESUM784976SGZ0 EUDAMEDESUM780692SG0 EUDAMEDESUM780469SGS0 EUDAMEDESUM7008650 EUDAMEDESUM780281SG0 EUDAMEDESUM780392SG0 EUDAMEDESUM783051SGS0 EUDAMEDESUM780437SG0 EUDAMEDESUM780178SGS0 EUDAMEDESUM780151SGS0 EUDAMEDESUM780168SG0 EUDAMEDESUM7002900 EUDAMEDESUM784984SGZ0 EUDAMEDESUM783193SGS0 EUDAMEDESUM782154SGS0 EUDAMEDESUM782296SL0 EUDAMEDESUM780191SG0 EUDAMEDESUME7001750 EUDAMEDESUM784996SGZ0 EUDAMEDESUM780179SG0 EUDAMEDESUM780395SG0 EUDAMEDESUME7002900 EUDAMEDESUM782181SG0 EUDAMEDESUM7881890 EUDAMEDESUM7002140 EUDAMEDESUM783051SG0 EUDAMEDESUM784956SGZ0 EUDAMEDESUM782489SG0 EUDAMEDESUM780238SG0 EUDAMEDESUM7879890 EUDAMEDESUM780191SLS0 EUDAMEDESUM7008600 EUDAMEDESUM784954SGSZ0 EUDAMEDESUM7001580 EUDAMEDESUM7022850 EUDAMEDESUM780272SGS0 EUDAMEDESUM784947SGSZ0 EUDAMEDESUM7002950 EUDAMEDESUM7001800 EUDAMEDESUM782183SLS0 EUDAMEDESUM780291SL0 EUDAMEDESUM700176SV20 EUDAMEDESUM780168SL0 EUDAMEDESUM780381SG0 EUDAMEDESUM782182SGS0 EUDAMEDESUME7001700 EUDAMEDESUM783197SGS0 EUDAMEDESUM7001510 EUDAMEDESUM780193SG0 EUDAMEDESUM7002060 EUDAMEDESUM780399SGS0 EUDAMEDESUM7001840 EUDAMEDESUM783052SGS0 EUDAMEDESUME7002840 EUDAMEDESUM7021810 EUDAMEDESUM780168SLS0 EUDAMEDESUM780454SG0 EUDAMEDESUM780194SG0 EUDAMEDESUM784997SGZ0 EUDAMEDESUM780167SL0 EUDAMEDESUME7002400 EUDAMEDESUM780479SG0 EUDAMEDESUM780194SGS0 EUDAMEDESUM7886870 EUDAMEDESUM7021800 EUDAMEDESUM782151SG0 EUDAMEDESUME7001580 EUDAMEDESUM7001750 EUDAMEDESUM7002870 EUDAMEDESUME7001600 EUDAMEDESUM7002480 EUDAMEDESUM782152SG0 EUDAMEDESUM7002460 EUDAMEDESUM7001920 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EUDAMEDESUM780797SG0 EUDAMEDESUME7001660 EUDAMEDESUM782297SLS0 EUDAMEDESUM782287SL0 EUDAMEDESUM784980SGZ0 EUDAMEDESUM7002440 EUDAMEDESUM7022840 EUDAMEDESUM780295SGS0 EUDAMEDESUM7008920 EUDAMEDESUM782189SLS0 EUDAMEDESUM780271SG0 EUDAMEDESUM782181SL0 EUDAMEDESUME7002850 EUDAMEDESUM783253SG0 EUDAMEDESUM784987SGSZ0 EUDAMEDESUM780394SGS0 EUDAMEDESUM784946SGSZ0 EUDAMEDESUM783052SG0 EUDAMEDESUM780291SLS0 EUDAMEDESUM780171SGS0 EUDAMEDESUM7008810 EUDAMEDESUME7001810 EUDAMEDESUM780243SG0 EUDAMEDESUM7008710 EUDAMEDESUM780160SG0 EUDAMEDESUM784990SGSZ0 EUDAMEDESUM780179SGS0 EUDAMEDESUM7001660 EUDAMEDESUM7877880 EUDAMEDESUM7001790 EUDAMEDESUM7002040 EUDAMEDESUM7001890 EUDAMEDESUM7887880 EUDAMEDESUM784994SGSZ0 EUDAMEDESUM783153SGS0 EUDAMEDESUME7001900 EUDAMEDESUM7001820 EUDAMEDESUM7008240 EUDAMEDESUM780175SG0 EUDAMEDESUME7002920 EUDAMEDESUM780196SGS0 EUDAMEDESUM7001610 EUDAMEDESUM7008250 EUDAMEDESUM7002940 EUDAMEDESUM780197SG0 EUDAMEDESUM780183SG0 EUDAMEDESUM780449SG0 EUDAMEDESUME7002420 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- 510(k) Number
- K150959 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- L180401 OPEN ELECTROSURGERY FORCEPS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Sutter Bipolar Forceps Calvian is a bipolar forceps designed for endoscopic surgical procedures, specifically for bipolar coagulation. It is classified under the product code GEI, indicating its use in general plastic surgery applications. The device delivers controlled electrical energy to achieve tissue coagulation with precision, facilitating minimally invasive surgical techniques.
This instrument is supplied in various configurations, including different shaft lengths, angles (15°, 45°, and 70°), and tip sizes ranging from 0.7 mm to 2.5 mm. It is intended for single-use and is manufactured by Sutter Medizintechnik GmbH, with regulatory authorizations including FDA 510K clearance under the Traditional pathway and compliance with the Medical Device Regulation (MDR). The device is intended for use in endonasal and transnasal endoscopic surgeries, where its ergonomic design enhances maneuverability around endoscopic instruments.
Frequently asked questions
What types of surgical procedures is the Sutter Bipolar Forceps-Calvian primarily used for, and why is its design important in those contexts?
The Sutter Bipolar Forceps-Calvian is designed specifically for endoscopic surgical procedures, particularly bipolar coagulation, where precise tissue sealing is required. Its ergonomic design and multiple shaft angles (15°, 45°, and 70°) enhance maneuverability, making it ideal for endonasal and transnasal surgeries. This flexibility allows surgeons to navigate tight spaces around other endoscopic instruments while delivering controlled electrical energy for coagulation, reducing collateral tissue damage and improving outcomes in minimally invasive procedures.
Are these forceps reusable, or are they intended for single-use only? How does this affect their clinical use?
The Sutter Bipolar Forceps-Calvian is intended for single-use only, as explicitly stated in the manufacturer’s specifications. This design choice minimizes the risk of cross-contamination, reduces the need for sterilization validation, and ensures consistent performance per procedure. Single-use instruments are particularly advantageous in endoscopic surgeries where sterility and precision are critical, as they eliminate potential degradation from repeated reprocessing.
What variations in size and configuration are available for the Sutter Bipolar Forceps-Calvian, and how might a clinician choose the right one for a procedure?
The device comes in multiple configurations to accommodate different surgical needs: shaft lengths (unspecified but likely standard for endoscopic use), three angled tips (15°, 45°, and 70°), and tip sizes ranging from 0.7 mm to 2.5 mm. A clinician would select based on the accessibility of the surgical site (e.g., narrower angles for confined spaces) and the tissue type/coagulation requirements (e.g., finer tips for delicate areas). The 70° angle, for instance, is ideal for deep or curved anatomical paths, while smaller tips may be preferred for precision tasks.
How should the Sutter Bipolar Forceps-Calvian be stored, and are there any special handling instructions to maintain its performance?
While the provided data does not specify storage conditions explicitly, single-use bipolar forceps like this typically require protection from moisture, extreme temperatures, and physical damage. Clinicians should store them in their original, sealed packaging until use, away from direct sunlight or sources of contamination. Proper handling ensures the device’s electrical insulation and coagulation precision remain intact, as compromised storage could affect performance during surgery.
What regulatory pathways does the Sutter Bipolar Forceps-Calvian follow, and what does this mean for its use in clinical settings?
The device holds FDA 510(k) clearance under the Traditional pathway (substantially equivalent to a predicate) and complies with the EU Medical Device Regulation (MDR). This means it has undergone premarket review to confirm safety and effectiveness, allowing its use in clinical settings in the U.S. and EU without additional restrictions. The product code GEI (General, Plastic Surgery) further categorizes it for endoscopic coagulation tasks, ensuring alignment with surgical standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Calvian endo-pen® - Sutter, Sutter Medizintechnik GmbH, Sutter Medical Technologies USA - Sutter
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150959 | Class II | Active |
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Manufacturer
- Manufacturer
- Sutter Medizintechnik GmbH
Sources (328)
- FDA 510(k) K150959 24 fields · synced Sep 30, 2026
- FDA UDI 302ceda5-0790-437c-9f97-89f6d87ab49c 35 fields · synced May 26, 2026
- FDA UDI c8139e22-5828-4b30-9d9e-d9a26507e70e 35 fields · synced May 26, 2026
- FDA UDI 913ee846-3ec3-4937-a430-f93108a3ddb5 35 fields · synced May 27, 2026
- FDA UDI 11f20bb6-a1e3-4d6f-b0fa-a8790325988c 35 fields · synced May 27, 2026
- FDA UDI a105db9a-ae00-4933-9477-226a298e5cd1 35 fields · synced May 29, 2026
- FDA UDI 4e999de9-f6e4-4637-af85-cd157b33d52b 35 fields · synced May 29, 2026
- FDA UDI 5e6bd200-aa19-48a6-9dab-b3219e4fd830 35 fields · synced May 29, 2026
- FDA UDI 937ce543-0b20-4262-95cb-d57821eeb365 35 fields · synced May 29, 2026
- FDA UDI 11374040-69f5-4ff2-82cf-ea042a2d7d64 35 fields · synced May 30, 2026
- FDA UDI 52242298-8a0f-4f47-8a9a-4d4c1606cab4 35 fields · synced May 30, 2026
- FDA UDI e00577e4-de7e-49b3-bb6e-8bfb539e5230 35 fields · synced May 30, 2026
- FDA UDI 68aea549-2a25-49d2-89fd-58e2ad8d0b45 35 fields · synced May 30, 2026
- FDA UDI faec9651-0712-4c0b-bd4c-8823956baa49 35 fields · synced May 30, 2026
- FDA UDI 8ec87125-d3e5-4c00-95fb-e1b21f12d9f9 35 fields · synced May 30, 2026
- FDA UDI dd44a3cb-7419-4ebd-93fc-a4175d41d3f1 35 fields · synced May 30, 2026
- FDA UDI eb948e33-97bb-49f7-b87a-be07bc75f406 35 fields · synced May 30, 2026
- FDA UDI 1ff406f1-82d1-4eef-9e7a-8a8bf24c417d 35 fields · synced May 30, 2026
- FDA UDI 02cef0f3-5f5c-44eb-bc58-a48a00c5f593 35 fields · synced May 30, 2026
- FDA UDI 07570877-91b2-4b40-a956-cdd7b464dc4d 35 fields · synced May 30, 2026
- FDA UDI 8a6c1f47-cf81-478c-840c-782de474cca2 35 fields · synced May 30, 2026
- FDA UDI 72a16343-4524-4931-a0c5-05e48fec7a7e 35 fields · synced May 30, 2026
- FDA UDI 8134a093-2eae-4501-8ef6-88642fd5f58e 35 fields · synced May 30, 2026
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- FDA UDI 0f17abf7-ecea-434b-bca0-32bad0ff9bb5 35 fields · synced May 30, 2026
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