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

    SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA

    K Number: K910985 · Decision Jul 5, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    121

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    Basic Information

    Device Name
    SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
    K Number
    K910985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Precision Laser Products, Inc.
    Date Received
    March 6, 1991
    Decision Date
    July 5, 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 Precision Laser Products, Inc.

    K Number Device Name
    K912853 PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)
    K910137 PLP LAPAROSCOPIC CHOLECYSTECTOMY SET
    K910184 PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES