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510(k) Data Aggregation

    K Number
    K133513
    Device Name
    MULTI-STAGE SNARE
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2013-12-20

    (38 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    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 US Endoscopy Multi-Stage snare is an elcctrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

    Device Description

    The US Endoscopy Multi-Stage snare is an elcctrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to United States Endoscopy Group, Inc. regarding their Multi-Stage snare device. This document confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements.

    However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot fulfill your request for that specific information based on the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report submitted as part of the 510(k) premarket notification.

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