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ENCISION, INC.

Last updated September 17, 2026

Information

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

Catalogue (237)

Page 2 of 5

Device	Model / Reference	Registries	Class	Status
Insert, Curved Maryland Dissector	ES0501-45	FDA UDI	Class II	Active
Insert, Maxi Grasper	ES0543	FDA UDI	Class II	Active
EM3 Monopolar Adapter, Universal	EM3-60+	FDA UDI	Class II	Active
Bipolar PowerGrip Forceps, 45cm	BP7601-45	FDA UDI	Class II	Active
AEM® Disposable Electrode, J-Hook	FC0310	FDA UDI	Class II	Active
AEM® Handle	ES8200	FDA UDI	Class II	Active
Curved Maryland Dissector, 23mm Jaw, Ratcheting Handle With Rotation, 45cm	EP3410-45RR	FDA UDI	Class II	Active
AEM® Cord, Disposable	ES4107-NSB	FDA UDI	Class II	Active
Bipolar Hirsch Style Forceps, 35cm	BP7302	FDA UDI	Class II	Active
Insert, Right Angle Dissector	ES0004	FDA UDI	Class II	Active
AEM® Disposable Handswitching Handpiece with Rocker Switch	ES1300	FDA UDI	Class II	Active
AEM® Disposable Kit	KT0120SC	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Diamond	ES0311-45	FDA UDI	Class II	Active
AEM® Shield Disposable Electrode, Spatula	FC0301+	FDA UDI	Class II	Active
Bipolar Instrument Cord, Covidien/Valleylab	BP4200V	FDA UDI	Class II	Active
Insert, Curved Maryland Dissector	ES0501	FDA UDI	Class II	Active
Rounded Maryland Dissector	ES0586-45	FDA UDI	Class II	Active
Fixed Tip Electrode, L-Wedge	ES3512B	FDA UDI	Class II	Active
AEM® Shield Disposable Electrode, L-Diamond	FC0311+	FDA UDI	Class II	Active
AEM® Disposable Kit	KT0102C	FDA UDI	Class II	Active
Insert, Fine Tooth Fenestrated Grasper	ES0014	FDA UDI	Class II	Active
Insert, Tapered Maryland Dissector	ES0526-45	FDA UDI	Class II	Active
AEM® Disposable Electrode, Spatula	FC0301-45	FDA UDI	Class II	Active
10mm Babcock w/ Straight Serrations, Ratcheting Handle, With Rotation	EP4320RR	FDA UDI	Class II	Active
Insert, Round Nose Grasper	ES0508	FDA UDI	Class II	Active
AEM® Monitor -ZE	EM3-ZE	FDA UDI	Class II	Active
Insert, Single Action Atraumatic Grasper	ES0570	FDA UDI	Class II	Active
Insert, Long Dolphin Nose Grasper	ES0512	FDA UDI	Class II	Active
AEM® Suction Irrigation Electrode J-Hook, 35cm	ES3774	FDA UDI	Class II	Active
5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation	EP3460-45RR	FDA UDI	Class II	Active
Disposable PowerGrip Bipolar Instrument Cord	BP4510	FDA UDI	Class II	Unknown
Angled Dissector, 5mm with 10mm shaft	EP4140RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, J-Hook	FC0310-45	FDA UDI	Class II	Active
AEM® Suction Irrigation Electrode L-Diamond, 35cm	ES3771	FDA UDI	Class II	Active
Wave Jaw Grasping Forcep, 35cm	EP3340RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Wedge	ES0312-45	FDA UDI	Class II	Active
AEM EndoShield® 2 Burn Protection System	EM200	FDA UDI	Class II	Active
Disposable Bipolar Forcep Cord	BP4510	FDA UDI	Class II	Active
Alligator Forcep, Ratcheting Handle With Rotation, 45cm	EP3080-45RR	FDA UDI	Class II	Active
5mm Glassman Forcep, Ratcheting Handle, With Rotation, 45cm	EP3040-45RR	FDA UDI	Class II	Active
5mm Dorsey Fenestrated Grasper, Slide Lock Handle	ES0522SL	FDA UDI	Class II	Active
Insert, Dissecting Forceps, Right Angled	ES0548	FDA UDI	Class II	Active
5mm Atraumatic Grasper, Ratcheting Handle, With Rotation	ES0537RR	FDA UDI	Class II	Active
Insert, Single Action Traumatic Grasper	ES0573-45	FDA UDI	Class II	Active
Insert, Blunt Nose Grasper	ES0009-45	FDA UDI	Class II	Active
Insert, Traumatic Grasper	ES0571	FDA UDI	Class II	Active
10mm Babcock Short Jaw, 35cm, Ratcheting Handle, With Rotation	EP4300RR	FDA UDI	Class II	Active
AEM® Disposable Kit	KT0102SC	FDA UDI	Class II	Active
5mm Glassman Forcep, Ratcheting Handle, With Rotation, 35cm	EP3040RR	FDA UDI	Class II	Active
Insert, Standard Grasper	ES0514	FDA UDI	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.