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

    SINGLE USE LAPARSCOPIC ELECTRODE

    K Number: K904240 · Decision Feb 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    159

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    Basic Information

    Device Name
    SINGLE USE LAPARSCOPIC ELECTRODE
    K Number
    K904240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Aspen Labs
    Date Received
    September 13, 1990
    Decision Date
    February 19, 1991
    Product Code
    HFG
    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
    HFG Coagulator, Laparoscopic, Unipolar (And Accessories)

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