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510(k) Data Aggregation

    K Number
    K963051
    Device Name
    ERCP CANNULA
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1997-03-28

    (234 days)

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

    ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.

    Device Description

    The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.

    AI/ML Overview

    The provided text is a summary of safety and effectiveness for Endoscopic Retrograde Cholangiopancreatography (ERCP) cannulas. It discusses the procedure, contraindications, and manufacturing overview for this medical device.

    However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or comparative effectiveness studies) as requested in your prompt.

    Therefore, I cannot populate the table or answer the specific questions based on the provided text. The text focuses on the device's intended use, contraindications for the procedure itself, and manufacturing quality control, rather than performance evaluation data.

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