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

    COAXIAL BALLOON GASTROESOPHAGEAL DILA

    K Number: K834451 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    47

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    Basic Information

    Device Name
    COAXIAL BALLOON GASTROESOPHAGEAL DILA
    K Number
    K834451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5365
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Thomas J. Fogarty, M.D.
    Date Received
    December 19, 1983
    Decision Date
    February 4, 1984
    Product Code
    KNQ
    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
    KNQ Dilator, Esophageal

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

    K Number Device Name
    K902453 OSCILLOMETRIC PULSE DETECTION DEVICE
    K884154 TRANSLUMINAL ENDARTERECTOMY DEVICE
    K831809 FOGARTY OCCLUDER PAD
    K841310 GASTROINTESTINAL DILATOR
    K831384 COAXIAL BALLOON URETHRAL DILATOR