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510(k) Data Aggregation

    K Number
    K203633
    Device Name
    Enteral Extension Sets
    Manufacturer
    GBUK Group Ltd
    Date Cleared
    2021-08-19

    (251 days)

    Product Code
    PIF
    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 Enteral Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for "Enteral Extension Sets." It does not contain information about the engineering details of the device's acceptance criteria, nor does it describe any study that proves the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth establishment, or human reader effectiveness from this document.

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