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

    DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM

    K Number: K921716 · Decision Nov 8, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    6
    Review Days
    578

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    Basic Information

    Device Name
    DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM
    K Number
    K921716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Surgical Instruments Corp.
    Date Received
    April 9, 1992
    Decision Date
    November 8, 1993
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by American Surgical Instruments Corp.

    K Number Device Name
    K921457 IRRIGATION PUMPS AND TUBING AND SUCTION TUBING
    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