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

    URETERO-RENOSCOPE

    K Number: K992527 · Decision Oct 13, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    URETERO-RENOSCOPE
    K Number
    K992527
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fiber Imaging Technologies, Inc.
    Date Received
    July 28, 1999
    Decision Date
    October 13, 1999
    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 Fiber Imaging Technologies, Inc.

    K Number Device Name
    K993300 COLDLIGHTSOURCE PL3000
    K992437 SCHOELLY RIGID ENDOSCOPES
    K992040 FLEXISCOPE II ARTHROSCOPES AND ACCESSORIES
    K991560 NASO-LARYNGO-PHARYNGOSCOPE