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510(k) Data Aggregation

    K Number
    K062385
    Device Name
    BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
    Manufacturer
    Grace Medical, Inc.
    Date Cleared
    2006-09-27

    (43 days)

    Product Code
    ETD
    Regulation Number
    874.3880
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K992222,K943325
    Why did this record match?
    Reference Devices :

    K992222, K943325

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

    Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment . A record of persistent high negative middle ear pressure associated with one or . more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both . Atelectasis resultant from retraction pocket of the tympanic membrane or . eustachian tube dysfunction.

    Device Description

    The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are manufactured from Blue (PTFE) Fluoroplastic and are supplied sterile. Various designs are available.

    AI/ML Overview

    This document is a 510(k) premarket notification for the Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes. It asserts substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

    Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria.

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