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510(k) Data Aggregation

    K Number
    K110804
    Device Name
    AMT G-J TUBE
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2011-10-19

    (211 days)

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

    AMT G-J TUBE

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

    The AMT Transgastric-Jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectorny or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom mainutrition already exists, or may result, secondary to concurrent conditions.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit. It concerns the regulatory approval of a medical device and does not contain information related to acceptance criteria, device performance, clinical study details, or ground truth establishment for an AI/CAD-like device. Therefore, I cannot extract the requested information from this document.

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