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510(k) Data Aggregation

    K Number
    K073718
    Device Name
    MEDLINE GASTROSTOMY TUBE
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Date Cleared
    2008-03-19

    (79 days)

    Product Code
    KGC
    Regulation Number
    876.5980
    Type
    Abbreviated
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDLINE GASTROSTOMY TUBE

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

    The Medline Gastrostomy Tube is designed as a percutaneous replacement tube which is inserted in a well-healed, mature gastric stoma. The device delivers liquid enteral formula and medications directly into the stomach.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Medline Gastrostomy Tube. It addresses the substantial equivalence of the device to legally marketed predicate devices. It does not contain information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory approval for a physical medical device, not an AI/ML software device.

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