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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 3 of 5

Device	Model / Reference	Registries	Class	Status
PowerGrip Instrument Shaft, 45cm	BP7550-45	FDA UDI	Class II	Active
Single Action Needle Holder, Ratcheting Handle, With Rotation, 35cm	EP3700RR	FDA UDI	Class II	Active
Insert, Single Action Traumatic Grasper	ES0573	FDA UDI	Class II	Active
AEM® Shield Disposable Electrode, J-Hook	FC0310+	FDA UDI	Class II	Active
Insert, Single Action Atraumatic Grasper	ES0570-45	FDA UDI	Class II	Active
Kocher Grasping Frocep, 35cm, 13mm Jaw	EP3400RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, Spatula	ES0301-45	FDA UDI	Class II	Active
5mm Dorsey Fenestrated Grasper, Ratcheting Handle, With Rotation	ES0522RR	FDA UDI	Class II	Active
AEM® Monitor	EM3	FDA UDI	Class II	Active
AEM EndoShield® Burn Protection System	EM100	FDA UDI	Class II	Active
AEM® Disposable Kit	KT0101SC	FDA UDI	Class II	Active
Insert, Kelly Forceps	ES0541	FDA UDI	Class II	Active
Insert, Strong Curved Maryland Dissector, 7-8mm	ES0533	FDA UDI	Class II	Active
Fixed Tip Electrode, Short Spatula	ES3501B	FDA UDI	Class II	Active
Adapter, SIE, Bard-Davol	ES3810	FDA UDI	Class II	Active
Fixed Tip Electrode, Ball Tip	ES3504B	FDA UDI	Class II	Active
Endo Clinch Extreme Atraumatic, 35cm Slide Lock Rotatable Handle	ES0535SLR	FDA UDI	Class II	Active
PowerGrip Instrument Shaft, 35cm	BP7550	FDA UDI	Class II	Active
EM3 Bipolar Adapter, Standard	BP9004+	FDA UDI	Class II	Active
Insert, Single Action Atraumatic Grasper	ES0570	FDA UDI	Class II	Active
5mm Endo Cinch Extreme Atraumatic Grasper, Slide Lock Handle, With Rotation	ES0535	FDA UDI	Class II	Active
AEM® Disposable Hook Scissors	ES0110-45	FDA UDI	Class II	Active
Bipolar Instrument Handle with Lock	BP7200L	FDA UDI	Class II	Active
Maxi Grasper, 35cm	ES0543RR	FDA UDI	Class II	Active
Insert, Maryland Dissector, Diamond Serrations	ES0547	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Wedge	FC0312	FDA UDI	Class II	Active
5mm Endo Cinch Extreme Atraumatic Grasper	ES0535-45	FDA UDI	Class II	Active
AEM® Burn Protection System Cable	ES6107+	FDA UDI	Class II	Active
Bipolar PowerGrip Forceps, 35cm	BP7601	FDA UDI	Class II	Active
Bipolar Kleppinger Forceps, 45cm	BP7301-45	FDA UDI	Class II	Active
Biopsy Forceps w/ Two Teeth, 35cm	EP3220RR	FDA UDI	Class II	Active
EM3 Monopolar Adapter, Universal	EM3-60	FDA UDI	Class II	Active
EM3 Bipolar Adapter, Standard	BP9004	FDA UDI	Class II	Active
Andrew Babcock Forcep, 45cm, 19mm Jaw, Ratcheting Handle with Rotation	EP3770-45RR	FDA UDI	Class II	Active
Long Allis Forcep, 35cm, with Ratchet and Rotate Handle	EP3010RR	FDA UDI	Class II	Active
Disposable Sheath	ES0150A	FDA UDI	Class II	Active
Insert, Mixter Clamp 90 Degree, Long	ES0538	FDA UDI	Class II	Active
Inhibit Adapter Extension	ES9008	FDA UDI	Class II	Active
Insert, Round Nose Grasper	ES0508-45	FDA UDI	Class II	Active
Bipolar Jumper Cord, Standard	ES9004	FDA UDI	Class II	Active
PowerGrip Instrument Handle	BP7500	FDA UDI	Class II	Active
Allis Forcep, 35cm	EP3000RR	FDA UDI	Class II	Active
Insert, Tapered Maryland Dissector	ES0526	FDA UDI	Class II	Active
Babcock Grasping Forcep, 35cm Ratcheting with Rotation Handle	EP3300RR	FDA UDI	Class II	Active
Insert, Fenestrated Bowel Grasper	ES0574-45	FDA UDI	Class II	Active
AEM® Disposable Hook Scissors	ES0110	FDA UDI	Class II	Active
Insert, Curved Scissors	ES0002-45	FDA UDI	Class II	Active
Insert, Petelin Dissector	ES0510	FDA UDI	Class II	Active
Insert, Fenestrated Bowel Grasper	ES0574	FDA UDI	Class II	Active
Insert, Fenestrated Bowel Grasper	ES0522	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.