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

    COAXIAL BALLOON URETHRAL DILATOR

    K Number: K831384 · Decision Jul 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    89

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    Basic Information

    Device Name
    COAXIAL BALLOON URETHRAL DILATOR
    K Number
    K831384
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5520
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Thomas J. Fogarty, M.D.
    Date Received
    April 28, 1983
    Decision Date
    July 26, 1983
    Product Code
    FAH
    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
    FAH Dilator, Urethral, Mechanical

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    Other Clearances by Thomas J. Fogarty, M.D.

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    K831809 FOGARTY OCCLUDER PAD
    K841310 GASTROINTESTINAL DILATOR
    K834451 COAXIAL BALLOON GASTROESOPHAGEAL DILA