BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇯🇵 Japan

    OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE

    K Number: K032092 · Decision Jul 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    188
    Registration Numbers
    188
    Same Product Code
    38
    Applicant Total
    22
    Review Days
    9

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    Basic Information

    Device Name
    OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
    K Number
    K032092
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Optical Co., Ltd.
    Date Received
    July 7, 2003
    Decision Date
    July 16, 2003
    Product Code
    FCL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCL Forceps, Biopsy, Non-Electric

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