BEUDAMED
    Product Code: FAF FDA class 3 21 CFR 876.3750

    Prosthesis, Testicular

    Gastroenterology, Urology

    The Testicular Prosthesis (product code FAF) is an implantable device used to restore the appearance and feel of a testicle following orchiectomy or in cases of testicular absence. It is an FDA Class 3 device (highest risk), requiring Premarket Approval (PMA); a call for PMAs was issued on July 5, 1995 per 60 FR 17216. It is regulated under 21 CFR 876.3750 in the Gastroenterology and Urology specialty. This device is designated as 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
    FAF
    Device Class
    FDA class 3
    Regulation Number
    876.3750
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    2

    Device Characteristics

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

    Definition

    Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95

    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.