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ENCISION, INC.

Last updated September 17, 2026

Information

Country: US
Address: 6797 WINCHESTER CIR., BOULDER, CO, 80301
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1000117361
DUNS Number: 612250175

Catalogue (237)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
AEM® Disposable Electrode, Spatula	FC0301	FDA UDI	Class II	Active
Fenestrating Grasping Forcep, 45cm	EP3280-45RR	FDA UDI	Class II	Active
AEM® Handle	ES8200L	FDA UDI	Class II	Active
5mm Debakey Tissue Forcep, Ratcheting Handle, With Rotation, 45cm	EP3250-45RR	FDA UDI	Class II	Active
5mm Endo Babcock Forcep, Ratcheting Handle, With Rotation	ES0534RR	FDA UDI	Class II	Active
10mm Claw Forcep, Ratcheting Handle, With Rotation	EP4200RR	FDA UDI	Class II	Active
Insert, Wave Grasper	ES0537-45	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Diamond	ES0311	FDA UDI	Class II	Active
AEM® Handle Hooded	ES8200H	FDA UDI	Class II	Active
Insert, Short Right Angle Dissector	ES0011	FDA UDI	Class II	Active
Insert, Fenestrated Grasping Forceps	ES0507	FDA UDI	Class II	Active
Long Allis Forcep, Ratcheting Handle With Rotation, 45cm	EP3010-45RR	FDA UDI	Class II	Active
Insert, Tapered Right Angle Dissector	ES0008	FDA UDI	Class II	Active
AEM® Burn Protection System Cable	ES5107	FDA UDI	Class II	Active
AEM® Disposable Electrode, J-Hook	ES0310-45	FDA UDI	Class II	Active
AEM® Disposable Curved Scissors	ES0102	FDA UDI	Class II	Active
AEM® Shield Disposable Electrode, J-Hook	FC0310-45+	FDA UDI	Class II	Active
Insert, Maryland Dissector, Aggressive	ES0549	FDA UDI	Class II	Active
Insert, Maxi Grasper	ES0543-45	FDA UDI	Class II	Active
Insert, Curved Scissors	ES0001	FDA UDI	Class II	Active
Insert, Tapered Micro-Fenestrated Grasper	ES0558	FDA UDI	Class II	Active
5mm Atraumatic Grasper, Slide Lock Handle, With Rotation	ES0537SLR	FDA UDI	Class II	Active
Insert, Straight Dissector	ES0513	FDA UDI	Class II	Active
AEM® Handle Hooded	ES8000HL	FDA UDI	Class II	Active
Fixed Tip Electrode, Needle Tip	ES3521B	FDA UDI	Class II	Active
Duckbill Forcep, 35cm	EP3140RR	FDA UDI	Class II	Active
Inhibit Adapter Extension	ES9007	FDA UDI	Class II	Active
Aem Disposable Suction Irrigation Electrodes	K131949	FDA 510(k)	Class II	Active
Endoshield Burn Protection System	K140006	FDA 510(k)	Class II	Active
Aem Disposable Suction Irrigation Handset Model Es1700; Aem Disposable Suction Irrigation Electrodes Model Es077x Series	K122580	FDA 510(k)	Class II	Active
Em3 Aem Monitor Aem Connectors	K122383	FDA 510(k)	Class II	Active
Disposable Handle Assembles, Models Dh0100 And Dh0500 Series	K090979	FDA 510(k)	Class II	Active
Aem Disposable Electrodes, Model Eso300 Series	K091074	FDA 510(k)	Class II	Active
Encision AEM enTouch 2X Scissor	K201018	FDA 510(k)	Class II	Active
Suction Irrigation Electrodes And Adapters	K100711	FDA 510(k)	Class II	Active
Aem Monitoring System, Models Em2, Emr, Es4007, Es4107, Es9005 And Es9015	K093622	FDA 510(k)	Class II	Active
Disposable Aem Fixed Tip Electrodes And Handpieces	K072789	FDA 510(k)	Class II	Active

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FDA Recalls (26)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 15, 2012	Z-1951-2012	—	terminated	Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.
Aug 24, 2011	Z-3097-2011	—	terminated	Electrode tips have been reported breaking off during use or cleaning.
Aug 24, 2011	Z-3093-2011	—	terminated	Electrode tips have been reported breaking off during use or cleaning.
Aug 24, 2011	Z-3094-2011	—	terminated	Electrode tips have been reported breaking off during use or cleaning.
Aug 24, 2011	Z-3096-2011	—	terminated	Electrode tips have been reported breaking off during use or cleaning.
Aug 24, 2011	Z-3095-2011	—	terminated	Electrode tips have been reported breaking off during use or cleaning.
Apr 7, 2011	Z-2397-2011	—	terminated	Sterility may be compromised due to holes in packaging.
Apr 7, 2011	Z-2395-2011	—	terminated	Sterility may be compromised due to holes in packaging.
Apr 7, 2011	Z-2396-2011	—	terminated	Sterility may be compromised due to holes in packaging.
Apr 7, 2011	Z-2400-2011	—	terminated	Sterility may be compromised due to holes in packaging.
Apr 7, 2011	Z-2399-2011	—	terminated	Sterility may be compromised due to holes in packaging.
Apr 7, 2011	Z-2398-2011	—	terminated	Sterility may be compromised due to holes in packaging.
Apr 5, 2010	Z-1546-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1540-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1542-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1541-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1545-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1544-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1539-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Apr 5, 2010	Z-1543-2010	—	terminated	Electrosurgical electrode tip insulation may crack and break off during use.
Jul 9, 2004	Z-1132-04	—	terminated	Firm found pinholes in packaging which would compromise sterility.
Jun 11, 2004	Z-1074-04	—	terminated	Electrosurgical tip may break or come off during use.
Jun 23, 2003	Z-1050-03	—	terminated	Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Jun 23, 2003	Z-1052-03	—	terminated	Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Jun 23, 2003	Z-1051-03	—	terminated	Use of NC versions of AEM monitor presents burn hazard when used with single pad and capacitively coupled patient return electrodes.
Jan 15, 2003	Z-0470-03	—	terminated	Reports of needle fixed-tip electrodes becoming loose or breaking off.