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    K Number
    K043254
    Device Name
    PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
    Manufacturer
    ONSET MEDICAL CORPORATION
    Date Cleared
    2005-02-10

    (78 days)

    Product Code
    EZN
    Regulation Number
    876.5470
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a working channel, admitting access to the ureter by way of the urethra and bladder, during endoscopic urological procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Expandable Ureteral Sheath." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving device performance based on the provided input. This type of information would typically be found in the 510(k) submission itself, which is a much larger document than this clearance letter.

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