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

    ISI METZENBAUM SCISSORS

    K Number: K934075 · Decision Dec 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    7
    Review Days
    103

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    Basic Information

    Device Name
    ISI METZENBAUM SCISSORS
    K Number
    K934075
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innovative Surgical, Inc.
    Date Received
    August 20, 1993
    Decision Date
    December 1, 1993
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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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
    K932697 ISI(R) HOOK SUTURE SCISSORS, MONOPOLAR
    K932698 ISI(R) HOOK SUTURES SCISSORS
    K932534 ISI FENESTRATED DISSECTING AND GRASPING FORCEPS