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K Number
K190643
Device Name
Medline Electrocautery Pencil
Manufacturer
Medline Industries, Inc.
Date Cleared
2019-05-06

(54 days)

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

The Medline Electrocautery Pencil is intended to be used in electrosurgical procedures to remove tissue and control bleeding by use of high frequency electrical current. The device can be used for both cutting and coagulating.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Medline Electrocautery Pencil. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

Therefore, I cannot provide the requested information from this document.

§ 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.