Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722040

FEI Number

1000117361

Entity Name

ENCISION, INC.

City/State/Country

BOULDER, CO, US

Establishment Address

6797 WINCHESTER CIR., BOULDER, CO 80301, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENCISION, INC. (Owner Number: 9003185)

Owner / Operator Contact Address

6797 WINCHESTER CIR., --, Boulder, CO 80301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122383

PMA Number

N/A

All Registered Proprietary Names

Inhibit Adapter Extensions Disposable AEM Cord Universal Adapter AEM Cord Adapter AEM Burn Protection Disposable System Cable AEM Endoshield 2 Burn Protection System EM200 AEM enTouch 2X Scissor EM3 Bipolar Adapters EM3 AEM Monitor EM3 Monopolar Adapters

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2010-12-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-28

Official Correspondent

Danielle Kaessner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENCISION, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722040. Last updated year: 2026. Please use registration number 1722040 when referencing this establishment in official correspondence.