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

    XTJF-160AF DUODENOVIDEOSCOPE

    K Number: K024033 · Decision Dec 20, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    34
    Applicant Total
    22
    Review Days
    14

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    Basic Information

    Device Name
    XTJF-160AF DUODENOVIDEOSCOPE
    K Number
    K024033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Optical Co., Ltd.
    Date Received
    December 6, 2002
    Decision Date
    December 20, 2002
    Product Code
    FDT
    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
    FDT Duodenoscope And Accessories, Flexible/Rigid

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    Other Clearances by Olympus Optical Co., Ltd.

    K Number Device Name
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    K021852 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
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    K023280 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
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