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

    GYRUS ACMI PK BUTTON ELECTRODE

    K Number: K093181 · Decision Feb 24, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    57
    Applicant Total
    42
    Review Days
    139

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    Basic Information

    Device Name
    GYRUS ACMI PK BUTTON ELECTRODE
    K Number
    K093181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Acmi, Inc.
    Date Received
    October 8, 2009
    Decision Date
    February 24, 2010
    Product Code
    FAS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FAS Electrode, Electrosurgical, Active, Urological

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