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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 4 of 5

Device	Model / Reference	Registries	Class	Status
Insert, Bullet Nose Grasper	ES0013	FDA UDI	Class II	Active
Insert, Curved Scissors	ES0001-45	FDA UDI	Class II	Active
10mm Spoon Forcep, Ratcheting Handle, With Rotation	EP4240RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Diamond	FC0311-45	FDA UDI	Class II	Active
AEM® Suction Irrigation Electrode L-Hook, 35cm	ES3773	FDA UDI	Class II	Active
Insert, Right Angle Dissector, 7mm, Diagonal Serrations	ES0559	FDA UDI	Class II	Active
Insert, Dolphin Nose Grasper	ES0511	FDA UDI	Class II	Active
PowerGrip Instrument Handle	BP7500	FDA UDI	Class II	Unknown
Mini Right Angle Dissector, Insert 35CM	ES0580	FDA UDI	Class II	Active
10mm Tenaculum, Ratcheting Handle, With Rotation	EP4370RR	FDA UDI	Class II	Active
Insert, Micro-Fenestrated Grasper	ES0557	FDA UDI	Class II	Active
AEM® Disposable Electrode, Square-L	FC0314	FDA UDI	Class II	Active
EM3 Monopolar Adapter, Universal	EM3-60-ZE	FDA UDI	Class II	Active
Endo Allis Forcep, 35cm with Ratchet and Rotate Handle	EP3480RR	FDA UDI	Class II	Unknown
Insert, Hook Scissors	ES0010	FDA UDI	Class II	Active
AEM enTouch 2X Scissor	ES0201-45	FDA UDI	Class II	Active
Fixed Tip Electrode, J-Hook	ES3510B	FDA UDI	Class II	Active
Insert, Fenestrated Bowel Grasper	ES0522-45	FDA UDI	Class II	Active
AEM® Disposable Curved Scissors	ES0101	FDA UDI	Class II	Active
Inhibit Adapter Extension	ES9009	FDA UDI	Class II	Active
Insert, Beveled Maryland Dissector, Tapered	ES0566	FDA UDI	Class II	Active
Endo Allis Forcep, 35cm	EP3030RR	FDA UDI	Class II	Active
5mm Endo Cinch Extreme Atraumatic Grasper, 35cm	ES0535RR	FDA UDI	Class II	Active
Fixed Tip Electrode, Flat J-Hook	ES3509B	FDA UDI	Class II	Active
5mm Retrograde Grasping Forcep, Ratcheting Handle, With Rotation	ES0536RR	FDA UDI	Class II	Active
AEM® Disposable Curved Scissors	ES0102-45	FDA UDI	Class II	Active
Insert, Blunt Nose Grasper	ES0009	FDA UDI	Class II	Active
5mm Atraumatic Grasper, Ratcheting Handle, With Rotation, 45cm	ES0537-45RR	FDA UDI	Class II	Active
Fenestrated Grasper, 35cm	ES0507RR	FDA UDI	Class II	Active
AEM® Shield Disposable Electrode, Spatula	FC0301-45+	FDA UDI	Class II	Active
AEM® Monitor	EM3+	FDA UDI	Class II	Active
Insert, Maryland Dissector, 90 Degree Tooth	ES0565	FDA UDI	Class II	Active
AEM® Cord Adapter	ES9005	FDA UDI	Class II	Active
AEM® Disposable Low Profile Scissors	ES0120	FDA UDI	Class II	Active
AEM® Cord, Disposable	ES4107	FDA UDI	Class II	Active
Adapter, SIE, Applied	ES3850	FDA UDI	Class II	Active
5mm Atraumatic Grasper, Slide Lock Handle, With Rotation, 45cm	ES0537-45SLR	FDA UDI	Class II	Active
AEM® Handle	ES8000L	FDA UDI	Class II	Active
Fixed Tip Electrode, L-Diamond	ES3511B	FDA UDI	Class II	Active
e·Access™ Slide-Lock Handle (rotatable)	ES8500-45SLR	FDA UDI	Class II	Active
Standard Grasper, 35cm with RR Handle	ES0514RR	FDA UDI	Class II	Active
5mm Fenestrated Grasper, Ratcheting Handle With Rotation, 45cm	ES0507-45RR	FDA UDI	Class II	Active
Fixed Tip Electrode, Button Tip	ES3520B	FDA UDI	Class II	Active
5mm Atraumatic Grasper S/A, Ratcheting Handle, With Rotation	EP3460RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, Square-L	FC0314-45	FDA UDI	Class II	Unknown
Permanent Adapter, SIE, Bard-Davol	ES3710	FDA UDI	Class II	Active
Fenestrated Bowel Grasper, 35cm, 20mm Jaw	EP3690RR	FDA UDI	Class II	Active
AEM® Disposable Electrode, L-Diamond	FC0311	FDA UDI	Class II	Active
Insert, Pointed Nose Grasper	ES0509	FDA UDI	Class II	Active
Insert, Traumatic Grasper	ES0571-45	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.