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

    Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)

    K Number: K230752 · Decision Sep 15, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    13
    Review Days
    182

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    Basic Information

    Device Name
    Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)
    K Number
    K230752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FUJIFILM Healthcare Americas Corporation
    Date Received
    March 17, 2023
    Decision Date
    September 15, 2023
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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