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510(k) Data Aggregation

    K Number
    K250128
    Date Cleared
    2025-09-19

    (245 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Single Use Suction-Evacuation Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones during endoscopic procedures.

    Device Description

    The Single Use Suction-Evacuation Ureteral Access Sheath is a single-use ureteral access sheath, which can create access to the urinary tract by provide ureteral dilation and a continuous working channel for the introduction of endoscope and instruments during ureteral access procedures. The device can inject fluids and has vacuum pressure design which can facilitate with stone cleaning procedures.

    The device consists of Dilator, Sheath, Sheath hub, Sealing cap, Dilator hub and Pressure control vent; Both dilator and sheath outer surfaces are coated with hydrophilic coatings, which provide longlasting lubrication for better expansion and passage. The distal end of the sheath (10cm) can bend with the endoscopes, and the tip is soft which provides seamless transition between sheath core and sheath tube. The dilator and sheath are designed with radiopaque which is visible under X-Ray, can be visualized under X-ray(fluoroscopy) during placement to confirm location.

    AI/ML Overview

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