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

    LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION

    K Number: K930716 · Decision Jul 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    7
    Review Days
    162

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    Basic Information

    Device Name
    LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION
    K Number
    K930716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gabris Surgical Corp.
    Date Received
    February 11, 1993
    Decision Date
    July 23, 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 Gabris Surgical Corp.

    K Number Device Name
    K954774 SHIELDED TROCAR (OBTURATOR)
    K953548 LAPAROSCOPIC SURGICAL INSTRUMENT
    K944640 LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT
    K944104 GABRIS LAPAROSCOPIC SURGICAL KITS
    K943989 LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
    K944103 LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT