BEUDAMED
    Product Code: QPT FDA class 3

    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

    Unknown

    The Implantable Electrical Tibial Stimulator for Urinary Incontinence is an implanted electrical stimulator, including an implanted power source, intended to treat overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve. This device is classified as FDA Class 3, the highest risk tier, requiring Premarket Approval (PMA), with no regulation number assigned, reviewed by the Gastroenterology and Urology panel. Product code QPT. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QPT
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.