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

    ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP

    K Number: K990456 · Decision Mar 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    85
    Review Days
    41

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    Basic Information

    Device Name
    ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
    K Number
    K990456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hollister, Inc.
    Date Received
    February 12, 1999
    Decision Date
    March 25, 1999
    Product Code
    KPI
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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