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

    PLP LAPAROSCOPIC CHOLECYSTECTOMY SET

    K Number: K910137 · Decision Apr 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    4
    Review Days
    89

    Basic Information

    Device Name
    PLP LAPAROSCOPIC CHOLECYSTECTOMY SET
    K Number
    K910137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    PRECISION LASER PRODUCTS, INC.
    Date Received
    January 9, 1991
    Decision Date
    April 8, 1991
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by PRECISION LASER PRODUCTS, INC.

    K Number Device Name
    K912853 PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
    K910985 SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
    K910184 PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES