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K Number
K972057
Device Name
POWERTREK INSTRUMENTS
Manufacturer
MEDTREK CORP.
Date Cleared
1997-11-05

(156 days)

Product Code
ERL
Regulation Number
874.4250
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The PowerTREK Instrument is indicated for use in the removal of tissue or bone in minimally invasive ENT and ,Orthopedic procedures. It is to be used within a surgical setting under sterile technique.

Device Description

Not Found

AI/ML Overview

There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for the PowerTREK Micro Debrider System, indicating that the device has been found substantially equivalent to predicate devices. It discusses regulatory classifications and general controls but does not contain details about specific performance studies, sample sizes, expert involvement, or adjudication methods.

§ 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.