BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ISI FENESTRATED DISSECTING AND GRASPING FORCEPS

    K Number: K932534 · Decision Aug 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    83

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    Basic Information

    Device Name
    ISI FENESTRATED DISSECTING AND GRASPING FORCEPS
    K Number
    K932534
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovative Surgical, Inc.
    Date Received
    May 28, 1993
    Decision Date
    August 19, 1993
    Product Code
    GFI
    Advisory Committee
    General, Plastic Surgery
    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
    GFI Osteotome, Manual

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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
    K932697 ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR
    K932698 ISI(R) HOOK SUTURES SCISSORS