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

    FUNS-10, FUNS-11

    K Number: K862551 · Decision Sep 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    71

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    Basic Information

    Device Name
    FUNS-10, FUNS-11
    K Number
    K862551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Reichert-Jung, Inc.
    Date Received
    July 3, 1986
    Decision Date
    September 12, 1986
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Reichert-Jung, Inc.

    K Number Device Name
    K864821 AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2
    K852994 REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11