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510(k) Data Aggregation

    K Number
    K062551
    Device Name
    NEXUS IRRIGATION TUBING SET
    Manufacturer
    NEXUS MEDICAL, LLC
    Date Cleared
    2006-12-15

    (107 days)

    Product Code
    LJH
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NEXUS IRRIGATION TUBING SET

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

    The Nexus Irrigation Tubing Set is intended for delivery of irrigating solutions from a container to an irrigation site during bladder irrigation, or endoscopic procedures such as cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter from the FDA for a medical device called the "Nexus Irrigation Tubing Set." The letter is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its commercialization, but it does not detail the technical studies that would typically include acceptance criteria and performance data.

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