BEUDAMED
    Product Code: MES FDA class 3

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    Unknown

    The permanent or semi-permanent bulbous urethral stent is a urology device designed to be placed within the bulbous urethra to relieve urethral strictures and maintain luminal patency in patients with recurrent urethral obstruction. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MES and no regulation number or formal medical specialty has been assigned. The device is not flagged as an implant in this record and does not sustain life.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

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

    Device Characteristics

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