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510(k) Data Aggregation

    K Number
    K050253
    Device Name
    USGI SHAPELOCK ENDOSCOPIC GUIDE
    Manufacturer
    USGI MEDICAL
    Date Cleared
    2005-02-28

    (25 days)

    Product Code
    FED
    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 USGI ShapeLock Endoscopic Guide is intented to be used with an endoscopes and removal of The USGI ShapeLock chooscopy, change of endoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "USGI ShapeLock™ Endoscopic Guide." It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt. The letter merely states that the device has been found substantially equivalent to legally marketed predicate devices and can be marketed.

    Therefore, I cannot extract the information needed to answer your request from this document.

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