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

    IRRIGATION PUMPS AND TUBING AND SUCTION TUBING

    K Number: K921457 · Decision May 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    413

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    Basic Information

    Device Name
    IRRIGATION PUMPS AND TUBING AND SUCTION TUBING
    K Number
    K921457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Surgical Instruments Corp.
    Date Received
    March 26, 1992
    Decision Date
    May 13, 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 American Surgical Instruments Corp.

    K Number Device Name
    K921716 DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
    K913944 NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES
    K913999 NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE
    K911274 UNIPOLAR COAGULATOR PROBE SYSTEM
    K896118 NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE