LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083210
    Device Name
    CORFLO ANTI IV ENTERAL FEEDING TUBE
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2008-12-29

    (59 days)

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

    CORFLO ANTI IV ENTERAL FEEDING TUBE

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

    The CORFLO® ANTI IV Enteral Feeding tube is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the CORFLO Anti IV Enteral Feeding Tube. While it states that the device is substantially equivalent to legally marketed predicate devices, it does not provide:

    • A table of acceptance criteria and reported device performance.
    • Details about specific studies, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either test or training sets.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1