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510(k) Data Aggregation

    K Number
    K040494
    Device Name
    CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2004-06-23

    (118 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144

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

    The disposable Capsule Delivery Device is a single sheathed device indicated for transendoscopic delivery of the M2A® Capsule Endoscope to the duodenum in patients who are either unable to swallow the M2A® Capsule Endoscope, or unable to pass the M2A® Capsule Endoscope beyond the pylorus in sufficient time to complete the desired diagnostic evaluation.

    Device Description

    The disposable Capsule Delivery Device is a single sheathed device.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a "Capsule Delivery Device" and does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices, but it does not detail any performance metrics or studies to support this. Therefore, I cannot extract the requested information from the provided text.

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