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

    LumenaTM Ureteral Access Sheath

    K Number: K250585 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    116
    Registration Numbers
    116
    Same Product Code
    100
    Applicant Total
    2
    Review Days
    120

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    Basic Information

    Device Name
    LumenaTM Ureteral Access Sheath
    K Number
    K250585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cathegenix (Xiamen) Co., Ltd.
    Date Received
    February 27, 2025
    Decision Date
    June 27, 2025
    Product Code
    FED
    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
    FED Endoscopic Access Overtube, Gastroenterology-Urology

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    Other Clearances by Cathegenix (Xiamen) Co., Ltd.

    K Number Device Name
    K251469 Endura™ Ureteral Stent and Stent Set