BEUDAMED
    Product Code: EZY FDA class 3 21 CFR 876.5280

    Device, Incontinence, Mechanical/Hydraulic

    Gastroenterology, Urology

    The Mechanical/Hydraulic Incontinence Device (product code EZY) is an implantable mechanical or hydraulic device used to manage urinary incontinence, typically by controlling the flow of urine through the urethra. It is an FDA Class 3 device (highest risk), requiring Premarket Approval (PMA); PMAs were required to be filed by December 26, 2000 (65 FR 57731). It is regulated under 21 CFR 876.5280 in the Gastroenterology and Urology specialty. This device is designated as an implant.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Research product code EZY 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
    EZY
    Device Class
    FDA class 3
    Regulation Number
    876.5280
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.