BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    NeuroTrac® MyoPlus Pro (MYO120U)

    K Number: K243079 · Decision Jun 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    1
    Review Days
    269

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    Basic Information

    Device Name
    NeuroTrac® MyoPlus Pro (MYO120U)
    K Number
    K243079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Verity Medical , Ltd.
    Date Received
    September 30, 2024
    Decision Date
    June 26, 2025
    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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