BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

    K Number: K243260 · Decision Apr 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    97
    Applicant Total
    64
    Review Days
    178

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    Basic Information

    Device Name
    FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
    K Number
    K243260
    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 Corporation
    Date Received
    October 15, 2024
    Decision Date
    April 11, 2025
    Product Code
    FET
    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
    FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

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