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

    XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

    K Number: K031256 · Decision Jul 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
    K Number
    K031256
    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 Opto-Electronics Co., Ltd.
    Date Received
    April 21, 2003
    Decision Date
    July 23, 2003
    Product Code
    FDA
    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
    FDA Enteroscope And Accessories

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    Other Clearances by Olympus Opto-Electronics Co., Ltd.

    K Number Device Name
    K032177 GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I