ENCISION, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
17220401000117361ENCISION, INC.1Y2026-01-016797 WINCHESTER CIR. BOULDER CO US 80301

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
441021849911349K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDGEI1991-12-30
441021623684971K201018Encision AEM enTouch 2X ScissorGEI2020-07-15
441021514713629K191612Encision AEM Monopolar Laparoscopic Instruments and AccessoriesGEI2020-03-20
441021501805540K140006ENDOSHIELD BURN PROTECTION SYSTEMGEI2014-06-16
441021115124643K122383EM3 AEM MONITOR AEM CONNECTORSGEI2013-01-10
441021897792531K100711SUCTION IRRIGATION ELECTRODES AND ADAPTERSGEI2010-06-09
441021551291012K093622AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015GEI2010-08-20
441021679917812K091074AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIESGEI2009-08-17
441021115124643
441021501805540
441021551291012
441021679917812
441021849911349
441021897792531

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI82020-07-15

PMN#

GUDID#

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