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    K Number
    K241185
    Device Name
    CORGRIP* SR NG/NI Tube Retention System
    Manufacturer
    Avanos Medical, Inc.
    Date Cleared
    2024-10-25

    (179 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORGRIP* SR NG/NI Tube Retention System

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

    The CORGRIP* SR Nasogastric/Nasointestinal (NG/N) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal of displacement of the tubes for adult patients.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used for testing/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or the type of ground truth used.

    The document is an FDA clearance letter for a medical device (CORGRIP* SR NG/NI Tube Retention System). It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements for the manufacturer. It specifies the indications for use but does not delve into the studies or data used to establish that equivalence or any performance metrics.

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