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

    Disposable Distal End Tape Hood

    K Number: K252457 · Decision Jan 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    6
    Review Days
    178

    Basic Information

    Device Name
    Disposable Distal End Tape Hood
    K Number
    K252457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai SeeGen Photoelectric Technology Co., Ltd.
    Date Received
    August 5, 2025
    Decision Date
    January 30, 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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