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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    HandX Instrument - Monopolar Spatula

    K Number: K222011 · Decision Jan 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    189

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    Basic Information

    Device Name
    HandX Instrument - Monopolar Spatula
    K Number
    K222011
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Human Xtensions , Ltd.
    Date Received
    July 7, 2022
    Decision Date
    January 12, 2023
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Human Xtensions , Ltd.

    K Number Device Name
    K223718 HandX™ Self-Righting Needle Holder
    K230491 HandX™ Monopolar Scissors
    K212214 HandX
    K203603 Monopolar Hook