BEUDAMED
    Product Code: QON FDA class 3 21 CFR 876.5270

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    Gastroenterology, Urology

    The Implanted Electrical Device Intended for Treatment of Fecal Incontinence is a Class 3 implantable electrical stimulation device for the treatment of chronic fecal incontinence, requiring Premarket Approval (PMA) due to its high-risk implantable nature and novel indication, under regulation 876.5270 in the Gastroenterology and Urology specialty. Product code QON. The device is flagged as an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    QON
    Device Class
    FDA class 3
    Regulation Number
    876.5270
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    Treatment of chronic fecal incontinence

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.