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

    BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS

    K Number: K864040 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    31
    Applicant Total
    645
    Review Days
    8

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    Basic Information

    Device Name
    BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS
    K Number
    K864040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.3630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    C.R. Bard, Inc.
    Date Received
    October 16, 1986
    Decision Date
    October 24, 1986
    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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