BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AEM e-Edge Disposable Scissor Inserts

    Reg #: 1722040 · FEI: 1000117361 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENCISION, INC.
    Registration Number
    1722040
    FEI Number
    1000117361
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6797 WINCHESTER CIR.
    City
    BOULDER
    State
    CO
    ZIP
    80301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191612

    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

    AEM e-Edge Disposable Scissor Inserts AEM enTouch Handles Reusable Dissector and Grasper Inserts Disposable and Reusable Scissors Inserts

    Establishment Types

    Manufacture Medical Device