BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ENCISION, INC.

    Reg #: 1722040 · FEI: 1000117361 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    18
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ENCISION, INC.
    Registration Number
    1722040
    FEI Number
    1000117361
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6797 WINCHESTER CIR.
    City
    BOULDER
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093622

    Owner / Operator

    Firm Name
    ENCISION, INC.
    Operator Number
    9003185
    Address
    6797 WINCHESTER CIR., --
    City
    Boulder
    State
    CO
    Postal Code
    80301
    Country
    US
    Correspondent
    Danielle Kaessner

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    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 AEM Disposable Monopolar Laparoscopic Electrodes, Cords, and Handpiece Reusable Fixed-Tip Electrodes Reusable Dissector and Grasper Inserts AEM e-Edge Disposable Scissor Inserts Disposable and Reusable Scissors Inserts AEM enTouch Handles Reusable Foot-Switching AEM Monopolar Laparoscopic Suction Irrigation Electrodes and Adapters

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility