LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K073034
    Device Name
    AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2008-03-14

    (140 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

    Initial placement of a perculaneous gastrostomy device may be indicated for patients with a functioning gut who requre long-term tube feeding. This includes patients in whom malnutrition already exists, or may result, seconda ry to concurrent conditions.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text content does not contain the information required to answer the request. The document is an FDA 510(k) clearance letter for a medical device (AMT Initial Placement GI Kit) and primarily discusses regulatory approval, not a study evaluating acceptance criteria or device performance. There is no mention of acceptance criteria, device performance metrics, sample sizes, data provenance, expert qualifications, ground truth, or details about a statistical study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1