BEUDAMED
    Product Code: JCW FDA class 3 21 CFR 876.3350

    Prosthesis, Penis, Inflatable

    Gastroenterology, Urology

    An inflatable penile prosthesis is a surgically implanted hydraulic device used to treat erectile dysfunction by allowing a patient to manually inflate implanted cylinders in the penis to achieve an erection, used when other therapies have failed. It is classified as FDA Class 3, the highest risk category, and requires Premarket Approval (PMA) demonstrating safety and effectiveness before marketing; PMAs were required to be filed by July 11, 2000, per 65 FR 19658. The product code is JCW, regulated under 21 CFR 876.3350, within the Gastroenterology and Urology medical specialty. This device is an implant.

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

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    Basic Information

    Product Code
    JCW
    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 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.