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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 1 of 5

Device	Model / Reference	Registries	Class	Status
AEM® Disposable Electrode, Spatula	ES0301	FDA UDI	Class II	Active
Fenestrated Bowel Grasper, 45cm, 20mm Jaw	EP3690-45RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, J-Hook	ES0310	FDA UDI	Class II	Active
Fixed Tip Electrode, 90 degree, L-Hook	ES3513B	FDA UDI	Class II	Active
Maxi Grasping Forcep, 35cm, 18mm Jaw Ratcheting with Rotation Handle	EP3380RR	FDA UDI	Class II	Active
Insert, Kelly Forceps	ES0541-45	FDA UDI	Class II	Active
Insert, Bowel Grasper	ES0521	FDA UDI	Class II	Active
AEM® Disposable Curved Scissors	ES0101-45	FDA UDI	Class II	Active
5mm Endo Cinch Extreme Atraumatic Grasper, 45cm	ES0535-45RR	FDA UDI	Class II	Active
AEM® Shield Disposable Electrode, L-Diamond	FC0311-45+	FDA UDI	Class II	Active
e·Access™ Slide-Lock Handle (rotatable)	ES8500SLR	FDA UDI	Class II	Active
AEM enTouch 2X Scissor	ES0202	FDA UDI	Class II	Active
AEM® Handle	ES8000	FDA UDI	Class II	Active
Ripple Claw Forcep, 45cm, 23mm Jaw	EP3480-45 RR	FDA UDI	Class II	Active
5mm Tenaculum, Ratcheting Handle, With Rotation	EP3640RR	FDA UDI	Class II	Active
Insert, Single Action Atraumatic Grasper	ES0570-45	FDA UDI	Class II	Active
Rounded Maryland Dissector	ES0586	FDA UDI	Class II	Active
Insert, Curved Scissors	ES0002	FDA UDI	Class II	Active
Fixed Tip Electrode, Square-L	ES3514B	FDA UDI	Class II	Active
AEM® Suction Irrigation Electrode Spatula, 35cm	ES3772	FDA UDI	Class II	Active
Bipolar Kleppinger Forceps, 35cm	BP7301	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Wedge	FC0312-45	FDA UDI	Class II	Active
Insert, Straight Micrograsper	ES0553	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Wedge	ES0312	FDA UDI	Class II	Active
Fenestrating Grasping Forcep, 35cm	EP3280RR	FDA UDI	Class II	Active
AEM enTouch 2X Scissor	ES0201	FDA UDI	Class II	Active
Traumatic Grasper, 35cm	EP3020RR	FDA UDI	Class II	Active
Adapter, SIE, Applied	ES3810	FDA UDI	Class II	Unknown
AEM enTouch 2X Scissor	ES0202-45	FDA UDI	Class II	Active
AEM® Monitor, Loaner	EM3-ZD	FDA UDI	Class II	Active
AEM® Handle, Hooded	ES8000H	FDA UDI	Class II	Active
Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cm	EP3100RR	FDA UDI	Class II	Active
Insert, Bowel Grasper	ES0521-45	FDA UDI	Class II	Active
Insert, 90 Degree Grasper	ES0506	FDA UDI	Class II	Active
AEM® Handle Hooded	ES8200HL	FDA UDI	Class II	Active
Insert, Dissecting Forceps, Right Angled, Cross Serrated	ES0552	FDA UDI	Class II	Active
Disposable Sheath	ES0150-45	FDA UDI	Class II	Active
Insert, Bottle Nose Grasper	ES0012	FDA UDI	Class II	Active
5mm Cobra Jaw Grasping Forcep, Ratcheting Handle, With Rotation	ES0540RR	FDA UDI	Class II	Active
Bipolar Instrument Tube Assembly, 35cm	BP7250	FDA UDI	Class II	Active
5mm Allis Forcep, Ratcheting Handle With Rotation, 45cm	EP3000-45RR	FDA UDI	Class II	Active
10mm Paddle Babcock, Ratcheting Handle, With Rotation	EP4340RR	FDA UDI	Class II	Active
Insert, Hook Scissors	ES0010-45	FDA UDI	Class II	Active
5mm Debakey Tissue Forcep, Ratcheting Handle, With Rotation, 35cm	EP3250RR	FDA UDI	Class II	Active
5mm Andrew Babcock Forcep, Ratcheting Handle, With Rotation	EP3770RR	FDA UDI	Class II	Active
Insert, Wave Grasper	ES0537	FDA UDI	Class II	Active
Ripple Claw Forcep, 35cm, 23mm Jaw	EP3480RR	FDA UDI	Class II	Active
Fixed Tip Electrode, Corson Needle	ES3523B	FDA UDI	Class II	Active
5mm Atraumatic Grasper, Slide Lock Handle	ES0537SL	FDA UDI	Class II	Active
Bipolar Instrument Tube Assembly, 35cm	BP7250-45	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.