BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS

    K Number: K082006 · Decision Oct 20, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    31
    Applicant Total
    72
    Review Days
    97

    Basic Information

    Device Name
    AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    K Number
    K082006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.3630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Received
    July 15, 2008
    Decision Date
    October 20, 2008
    Product Code
    FAE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FAE Prosthesis, Penile

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