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K Number
K173889
Device Name
Medline Cautery Electrode (PTFE)
Manufacturer
Medline Industries, Inc.
Date Cleared
2018-04-09

(109 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Medline PTFE Cautery Electrode is intended to cut and/or coagulate soft tissues by means of high frequency electrical current during electrosurgical procedures.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) summary for a Medline Cautery Electrode (PTFE). It is a letter from the FDA determining substantial equivalence for a medical device. This document does not contain information regarding the acceptance criteria, study details, or performance of a device that uses AI. The product described is an electrosurgical cutting and coagulation device accessory, which is a physical device, not an AI or software-based system.

Therefore, I cannot provide the requested information about acceptance criteria and studies related to an AI device's performance based on this input.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.