Identity
- Trade Name
- Bipolar Forceps FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, bipolar, reusable FDA UDI
- Device Name
- Bipolar ring-forceps, straight, angled, very fine, ring-ø ad 1.0 mm, 16 cm, guide pin FDA UDI
- Model / Reference
- 80-201-01 FDA UDI
- Description
- Bipolar ring-forceps, straight, angled, very fine, ring-ø ad 1.0 mm, 16 cm, guide pin FDA UDI
Identifiers
- Catalog Number
- 80-201-01 FDA UDI
- Primary DI / UDI-DI
- 04250381892787 FDA UDI
- 510(k) Number
- K101080 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 16 Centimeter FDA UDI
Category: Endoscopic electrosurgical electrode, bipolar, reusable
Bipolar Forceps by Spiggle & Theis Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical electrode, bipolar, reusable.
- CONMED — Conmed Corporation · Class II
- TAKE-APART — Karl Storz GmbH & Co. KG · Class II
- Adler Instrument Company — Adler, Inc. · Class II
- Delasco Bipolar Forceps — DERMATOLOGIC LAB AND SUPPLY, INC. · Class II
- TAKE-APART — Karl Storz GmbH & Co. KG · Class II
- Gimmi — Gimmi GmbH · Class II
- Gimmi — Gimmi GmbH · Class II
- CONMED — Conmed Corporation · Class II
Cleared under the same submission
K101080 also covers:
- BIPOLAR BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR COAPTATION FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR HARDY BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR HARDY FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR JENSEN BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR JENSEN BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR JEWELERS FORCEPS — SONTEC INSTRUMENTS, INC.
- BIPOLAR YASARGIL BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET WIDE GRIP FORCEPS — SONTEC INSTRUMENTS, INC.
- BLACK BIPOLAR BAYONET WIDE GRIP FORCEPS — SONTEC INSTRUMENTS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spiggle & Theis Medizintechnik GmbH
Sources (1)
- FDA UDI b0ef9981-6fb1-41eb-8f16-fae416e4a558 37 fields · synced Jun 8, 2026