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

    SILASTIC BRAND PENILE IMPLANT

    K Number: K780484 · Decision Jul 17, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    31
    Review Days
    112

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    Basic Information

    Device Name
    SILASTIC BRAND PENILE IMPLANT
    K Number
    K780484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    March 27, 1978
    Decision Date
    July 17, 1978
    Product Code
    FIQ
    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
    FIQ Cannula, A-V Shunt

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