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

    GABRIS LAPAROSCOPIC SURGICAL KITS

    K Number: K944104 · Decision Sep 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    GABRIS LAPAROSCOPIC SURGICAL KITS
    K Number
    K944104
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5090
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gabris Surgical Corp.
    Date Received
    August 23, 1994
    Decision Date
    September 13, 1994
    Product Code
    FBQ
    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
    FBQ Trocar, Gastro-Urology

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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
    K943989 LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT
    K944103 LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
    K930716 LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION