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510(k) Data Aggregation

    K Number
    K123438
    Device Name
    XENX STONE MANAGEMENT DEVICE
    Manufacturer
    XENOLITH MEDICAL
    Date Cleared
    2013-01-10

    (63 days)

    Product Code
    OCY,FFL
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy and to facilitate the placement of endourological instruments during diagnostic or interventional procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes an FDA 510(k) clearance for the XenX™ Stone Management Device and outlines its indications for use, but it does not detail any acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment methods for a device performance study. This document is a regulatory clearance letter, not a study report.

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