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

    Fujifilm Duodenoscope Model ED-530XT

    K Number: K152257 · Decision Jul 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    34
    Applicant Total
    39
    Review Days
    711

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    Basic Information

    Device Name
    Fujifilm Duodenoscope Model ED-530XT
    K Number
    K152257
    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 Medical Systems U.S.A, Inc.
    Date Received
    August 10, 2015
    Decision Date
    July 21, 2017
    Product Code
    FDT
    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
    FDT Duodenoscope And Accessories, Flexible/Rigid

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