BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Endoscopic Distal Attachments

    K Number: K260423 · Decision May 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    8
    Review Days
    108

    Basic Information

    Device Name
    Disposable Endoscopic Distal Attachments
    K Number
    K260423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Yangzhou Fartley Medical Instrument Technology Co., Ltd.
    Date Received
    February 9, 2026
    Decision Date
    May 28, 2026
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

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