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510(k) Data Aggregation

    K Number
    K152035
    Device Name
    iSnare system-Lariat
    Manufacturer
    United States Endoscopy Group, Inc
    Date Cleared
    2015-10-15

    (85 days)

    Product Code
    FBK,FDI
    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

    The US Endoscopy iSnare system - Lariat is intended to be used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures. The device can be used with or without monopolar diathermic energy.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be an FDA 510(k) clearance letter for the "I-snare System-Lariat," a medical device used in gastrointestinal endoscopy. This document does not contain any information about acceptance criteria, device performance results, or a clinical study that proves the device meets specific acceptance criteria.

    The letter is a regulatory filing indicating that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device's safety and effectiveness are considered comparable to devices already on the market, based on its indications for use, technological characteristics, and often, non-clinical performance data.

    Therefore, I cannot provide the requested information from the provided text. The document is strictly a regulatory clearance and does not detail a study proving specific performance metrics against acceptance criteria.

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