BEUDAMED
    Product Code: FAC FDA class 3

    Valve, Ureterovesicle

    Unknown

    The Ureterovesicle Valve (product code FAC) is an implantable device designed to create or restore a valve-like mechanism at the junction between the ureter and the bladder to prevent urinary reflux. It is an FDA Class 3 device (highest risk), requiring Premarket Approval (PMA). No regulation number or medical specialty designation has been formally assigned. This device is designated as an implant and is reviewed by the Gastroenterology and Urology panel.

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

    Research product code FAC in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    FAC
    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