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510(k) Data Aggregation

    K Number
    K250132
    Date Cleared
    2025-09-05

    (231 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 ureteral access sheath is used to establish a working channel during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. The intended population of this device should be adult only.

    This is a single-use device. A re-sterilization by users and re-use of the device are not allowed.

    Device Description

    The Ureteral Access Sheath consist of an outer sheath, a tapered dilator and their sockets. The hydrophilic coating are applied to the sheath and the tip of dilator.

    The Ureteral Access Sheath is a single use sterile single-lumen access sheath, it contains two models of devices, FS and GS. The FS type can be available with inner diameters ranging from 9 to 15 French and lengths ranging from 35 to 55 cm. and the GS type can be available with inner diameters ranging from 9 to 15 French, and lengths ranging form 20 to 55 cm.

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