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510(k) Data Aggregation

    K Number
    K131532
    Device Name
    ELECTROMAGNETIC TRANSMITTING STYLET
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2013-08-12

    (76 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    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 Electromagnetic Transmitting Stylet has been specifically designed for use with the CORTRAK 2 Enteral Access System (EAS), and is intended to aid in the confirmation of NG decompression tubes.

    Device Description

    Electromagnetic Transmitting Stylet

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for an "Electromagnetic Transmitting Stylet" and only specifies the device's indications for use and the regulatory pathway. It does not include details about device performance, studies, or acceptance criteria.

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