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

    Disposable ureteral stent

    K Number: K243830 · Decision May 14, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    3
    Review Days
    152

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    Basic Information

    Device Name
    Disposable ureteral stent
    K Number
    K243830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Trious Medical Technology Co., Ltd.
    Date Received
    December 13, 2024
    Decision Date
    May 14, 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 Shenzhen Trious Medical Technology Co., Ltd.

    K Number Device Name
    K250448 Disposable Percutaneous Nephrostomy Dilatation Kit
    K243710 Disposable ureteral access sheath