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

    Disposable Ureteral Stents

    K Number: K251890 · Decision Feb 20, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    13
    Review Days
    245

    Basic Information

    Device Name
    Disposable Ureteral Stents
    K Number
    K251890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Chuangxiang Medical Technology Co., Ltd.
    Date Received
    June 20, 2025
    Decision Date
    February 20, 2026
    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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    K220065 Single Use Ureteral Access Sheath
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    K191900 Single Use Grasping Forceps
    K192258 Disposable Valve Sets
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