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

    Ureteral Stents (AF-D series)

    K Number: K243039 · Decision Jun 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    6
    Review Days
    264

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    Basic Information

    Device Name
    Ureteral Stents (AF-D series)
    K Number
    K243039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alton (Shanghai) Medical Instruments Co., Ltd.
    Date Received
    September 27, 2024
    Decision Date
    June 18, 2025
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Alton (Shanghai) Medical Instruments Co., Ltd.

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