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510(k) Data Aggregation

    K Number
    K250585
    Device Name
    LumenaTM Ureteral Access Sheath
    Manufacturer
    CatheGenix (Xiamen) Co., Ltd.
    Date Cleared
    2025-06-27

    (120 days)

    Product Code
    FED
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CatheGenix (Xiamen) Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
    Device Description
    The LumenaTM Ureteral Access Sheaths are designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The sheaths are available with both a bendable tip with a Y-shape joint on the proximal end and a straight tip with the outside diameters ranging from 11 to 15 French and lengths ranging from 35 to 45 centimeters. These devices are available in a single lumen configuration and include a sheath tube and a dilator. The bendable-tip sheath is intended to be connected to a negative pressure aspirator for the collection of stones or foreign bodies during the endoscopic procedure.
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