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K Number
K981310
Device Name
MAGNATEK C-300
Manufacturer
MAGNA ADVANCED TECHNOLOGIES, INC.
Date Cleared
1998-07-09

(90 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

C-300 Coagulator is used in small surgical procedures in The dermatology, plastic surgery and general surgery in order to only coagulate (burn) an open wound or skin lesions. This device does not cut the skin, it only closes open wounds or lesions by coagulating (burning) the skin in any of the small surgical procedures mentioned above.

Device Description

Coagulator Device Name: C-300

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "MagnaTek C-300 Coagulator". It does not contain information about acceptance criteria or a study proving the device meets them. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the given text.

§ 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.