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510(k) Data Aggregation

    K Number
    K140763
    Device Name
    MONOFILAMENT POLYPECTOMY SNARE
    Manufacturer
    UNITED STATES ENDOSCOPY
    Date Cleared
    2014-04-24

    (28 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 Monofilament polypectomy snare is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures.

    Device Description

    Monofilament polypectomy snare

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Monofilament polypectomy snare" and primarily discusses the regulatory approval process and requirements. It does not include details about device performance, clinical studies, or specific acceptance criteria.

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