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

    DEVINE (SUPRAPUBIC SOUND AND GUIDE)

    K Number: K873177 · Decision Oct 14, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    63

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    Basic Information

    Device Name
    DEVINE (SUPRAPUBIC SOUND AND GUIDE)
    K Number
    K873177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Penn Medical Devices, Inc.
    Date Received
    August 12, 1987
    Decision Date
    October 14, 1987
    Product Code
    KOE
    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
    KOE Dilator, Urethral

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    Other Clearances by Penn Medical Devices, Inc.

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