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510(k) Data Aggregation

    K Number
    K151197
    Device Name
    Lariat snare
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    2015-07-06

    (62 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Lariat snare

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

    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy,

    Device Description

    The Lariat snare is an electrosurgical device designed to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

    AI/ML Overview

    This document is a 510(k) clearance letter for the Lariat Snare, an electrosurgical device. It outlines the FDA's determination of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML or diagnostic device performance.

    Therefore, I cannot provide the requested information. The document focuses solely on the regulatory clearance process for a traditional medical device, not a device with AI components or one that requires validation through clinical study performance metrics in the way your prompt describes.

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