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510(k) Data Aggregation

    K Number
    K043203
    Date Cleared
    2005-05-11

    (174 days)

    Product Code
    Regulation Number
    876.5980
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE

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

    This device is intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel. The device is supplied sterile and is intended for single use only.

    Device Description

    The proposed Nasal Jejunal Feeding Tube is a single lumen, radiopaque PVC tube. The 8Fr and 10Fr diameter tubes are intended to be introduced endoscopically and are supplied with a wire guide. The 14FR tube with flaps is intended to be introduced manually in conjunction with peristalsis into the jejunum. The distal portions of all tubes have feed ports for delivery of liquid nutrition and/or medication. All tube kits include a nasal transfer tube and feeding adapters.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Wilson-Cook Nasal Jejunal Feeding Tubes. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria, detailed study designs, performance data (other than a general statement of "performance characteristics tested"), sample sizes, or expert involvement.

    Therefore, I cannot provide the requested table and information based on the given text.

    The only "performance data" mentioned is:
    "We believe the proposed device to be substantially equivalent to the named predicate based on performance characteristics tested." This statement is too vague to extract any specific acceptance criteria or study details.

    In summary, the document lacks the necessary information to answer your questions thoroughly.

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