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

    LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR

    K Number: K914098 · Decision Oct 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    3
    Review Days
    46

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    Basic Information

    Device Name
    LAPAROSCOPIC MINI-DISSECTOR/RIGHT ANGLE RETRACTOR
    K Number
    K914098
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Innovations Corp.
    Date Received
    September 12, 1991
    Decision Date
    October 28, 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 Surgical Innovations Corp.

    K Number Device Name
    K944292 SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE
    K934105 DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES