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510(k) Data Aggregation

    K Number
    K955181
    Device Name
    U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Date Cleared
    1996-06-05

    (205 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 Gastrostomy tube is replaced with a Replacement Gastrostomy Tube for such things as indications of a blocked feeding tube, patient comfort and esthetics, and the need for long-term nutritional support.

    Device Description

    Replacement Gastrostomy Tube

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample size, ground truth, or study details for a medical device. The document describes a "Replacement Gastrostomy Tube" and general information about its use, manufacturing, and sterility, along with a bibliography of related medical articles. It does not contain the specific type of data requested in your prompt regarding a study's acceptance criteria and performance results.

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