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

    Defendo Fujifilm 700 Single Use Cleaning Adapter

    K Number: K250140 · Decision Feb 20, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    34

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    Basic Information

    Device Name
    Defendo Fujifilm 700 Single Use Cleaning Adapter
    K Number
    K250140
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Steris Corparation
    Date Received
    January 17, 2025
    Decision Date
    February 20, 2025
    Product Code
    ODC
    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
    ODC Endoscope Channel Accessory

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