BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOSCOPIC CLIP APPLIER

    K Number: K911817 · Decision Jun 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    48

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    Basic Information

    Device Name
    ENDOSCOPIC CLIP APPLIER
    K Number
    K911817
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgitech C/O Collier, Shannon, Rill & Scott
    Date Received
    April 24, 1991
    Decision Date
    June 11, 1991
    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 Surgitech C/O Collier, Shannon, Rill & Scott

    K Number Device Name
    K874450 SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT