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510(k) Data Aggregation

    K Number
    K960632
    Device Name
    KANGAROO FEEDING TUBE PLACMENT STYLET
    Manufacturer
    SHERWOOD MEDICAL CO.
    Date Cleared
    1996-05-09

    (85 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K822875,K831868,K833621,K914375,K894857
    Why did this record match?
    Reference Devices :

    K822875, K831868, K833621, K914375

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

    The function of the stylet is to provide the necessary stiffness to aid the clinician in the placement of a nasointestinal feeding tube.

    Device Description

    The Kangaroo® Stylets are comprised of a stainless steel wire that terminates at its distal end welded to an atraumatic stainless steel spring. The proximal end of the stainless stylet wire is mechanically attached to a flow-through male polypropylene luer hub.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device (Kangaroo® Pedi-Tube Flow Through Stylet & Kangaroo® Flow-Through Stylet) and its substantial equivalence to other devices, but it does not detail any acceptance criteria, performance studies, or related data such as sample sizes, expert qualifications, or ground truth establishment. This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results like those you've asked for.

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