LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972400
    Device Name
    MYRINGOTOMY TUBE - BOBBIN WITH TAB
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1997-07-23

    (48 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MedNet Locator, INC., bobbin with tab myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.

    Device Description

    Myringotomy Tube - Bobbin with Tab

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any comparative effectiveness studies.

    The document is a 510(k) clearance letter from the FDA for a "Myringotomy Tube - Bobbin with Tab." It primarily states that the device is substantially equivalent to legally marketed devices and can therefore be marketed. It also includes the stated "Indications For Use" for the device.

    Therefore, I cannot provide the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1