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510(k) Data Aggregation

    K Number
    K063118
    Device Name
    BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2007-02-13

    (125 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K915841
    Predicate For
    K092049,K100173
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation.

    Also for percutaneous replacement of a gastrostomy feeding and/or decompression device into an established stoma site.

    Device Description

    Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube

    AI/ML Overview

    I am sorry, but the provided document does not contain information on acceptance criteria, device performance, a study, or any of the specific details you requested regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document is a 510(k) summary and FDA clearance letter for a medical device (Bard® Balloon Dilation Kit with Tri-Funnel Gastrostomy Tube). It outlines general information about the device, its intended use, and its substantial equivalence to a predicate device, but it does not include the type of detailed performance study results you are looking for.

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