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

    ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR

    K Number: K932697 · Decision Nov 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    7
    Review Days
    160

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    Basic Information

    Device Name
    ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR
    K Number
    K932697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovative Surgical, Inc.
    Date Received
    June 3, 1993
    Decision Date
    November 10, 1993
    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 Innovative Surgical, Inc.

    K Number Device Name
    K945394 INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER
    K932695 ISI(R) PORPOISE NOSE DISSECTING FORCEPS
    K932696 ISI(R) CURVED, TAPERED DISSECTING FORCEPS
    K934075 ISI METZENBAUM SCISSORS
    K932698 ISI(R) HOOK SUTURES SCISSORS
    K932534 ISI FENESTRATED DISSECTING AND GRASPING FORCEPS