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510(k) Data Aggregation

    K Number
    K991394
    Device Name
    STAPES PROSTHESES
    Manufacturer
    Grace Medical, Inc.
    Date Cleared
    1999-05-18

    (27 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Type
    Special
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STAPES PROSTHESES

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

    Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctible injury to the middle ear from trauma

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for "Stapes Prostheses," which declares the device substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not contain details about performance studies, sample sizes, ground truth establishment, or expert involvement in such studies.

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