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

    PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR

    K Number: K993976 · Decision Feb 22, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    11
    Review Days
    90

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    Basic Information

    Device Name
    PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
    K Number
    K993976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Prometheus Group
    Date Received
    November 24, 1999
    Decision Date
    February 22, 2000
    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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    Other Clearances by The Prometheus Group

    K Number Device Name
    K160792 Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
    K030039 PATHWAY STM-10 PELVIC FLOOR STIMULATOR
    K023906 PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
    K001515 PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
    K974036 PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE
    K973537 PATHWAY ELECTROMYOGRAPH
    K960508 PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
    K960761 PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20
    K960762 SYNERGY PLUS
    K897132 PATHWAY II ELECTROMYOGRAPH
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