BEUDAMED
    Product Code: FHW FDA class 3 21 CFR 876.3350

    Device, Impotence, Mechanical/Hydraulic

    Gastroenterology, Urology

    The Mechanical/Hydraulic Impotence Device is a penile prosthesis or external device that uses mechanical or hydraulic mechanisms to produce or maintain an erection in patients with erectile dysfunction. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) from the FDA prior to marketing, reflecting the significant risks associated with its invasive, implanted nature. The product code is FHW, regulated under 21 CFR 876.3350, within the Gastroenterology, Urology specialty. This device is an implant.

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    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    FHW
    Device Class
    FDA class 3
    Regulation Number
    876.3350
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.