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510(k) Data Aggregation

    K Number
    K970945
    Device Name
    ANGLED TIP POLYPECTOMY SNARE
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1997-05-07

    (54 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    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 Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.

    Device Description

    A polypectory snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp. The Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.

    AI/ML Overview

    This 510(k) summary (K970945) describes a polypectomy snare, which is a medical device, not an AI/ML algorithm. Therefore, the requested information regarding acceptance criteria and studies proving device performance, especially those related to AI/ML specific aspects, are not applicable in this context.

    The document discusses the product's intended use, contraindications for the procedure, manufacturing processes, quality assurance, and sterility testing for this physical medical device. It does not mention any software, algorithms, AI, or machine learning components.

    Therefore, I cannot provide the requested information in the format specified, as the input document does not contain data relevant to AI/ML device performance studies.

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