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

    MODEL FUS-1, FLEXIBLE URETEROSCOPE

    K Number: K811535 · Decision Jun 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    35
    Review Days
    22

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    Basic Information

    Device Name
    MODEL FUS-1, FLEXIBLE URETEROSCOPE
    K Number
    K811535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Optical Corp.
    Date Received
    June 1, 1981
    Decision Date
    June 23, 1981
    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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