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510(k) Data Aggregation

    K Number
    K974174
    Device Name
    ULTRABUR
    Manufacturer
    MEDNET LOCATOR, INC.
    Date Cleared
    1998-03-10

    (124 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRABUR

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

    The MedNet LOCATOR, INC., ULTRABUR is to be used by ear, nose and throat physicians for forming a hole in the footplate for the placement of middle ear prostheses in stapedectomy procedures.

    Device Description

    ULTRABUR (Pheumatic Surgical Drill, Surgical Drill and Bur)

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a pneumatic surgical drill (MedNet UltraBur) and its indications for use. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

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