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

    Bladeless Trocar – Artemis Lap Cannula

    K Number: K231400 · Decision Aug 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    11
    Review Days
    81

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    Basic Information

    Device Name
    Bladeless Trocar – Artemis Lap Cannula
    K Number
    K231400
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    T.A.G. Medical Products Corporation, Ltd.
    Date Received
    May 15, 2023
    Decision Date
    August 4, 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 T.A.G. Medical Products Corporation, Ltd.

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