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

    UNIPOLAR COAGULATOR PROBE SYSTEM

    K Number: K911274 · Decision Jun 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    UNIPOLAR COAGULATOR PROBE SYSTEM
    K Number
    K911274
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Surgical Instruments Corp.
    Date Received
    March 22, 1991
    Decision Date
    June 20, 1991
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by American Surgical Instruments Corp.

    K Number Device Name
    K921716 DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
    K921457 IRRIGATION PUMPS AND TUBING AND SUCTION TUBING
    K913944 NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES
    K913999 NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE
    K896118 NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE