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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
EN
Reference & Predicate Devices
N/A
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.

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.