MSI TA ELECTRODES

• K Number: K024266
• Device Name: MSI TA ELECTRODES
• Manufacturer: MEDSPHERE INTERNATIONAL, INC
• Date Cleared: 2003-03-12 ( 79 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Indicated for coagulation of soft tissue. These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding "MSI TA Electrodes" for electrosurgical cutting and coagulation. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it include performance metrics, sample sizes, expert qualifications, or details about ground truth establishment.

Therefore, I cannot answer your request based on the provided input. This document is a regulatory approval letter, not a scientific study report.

Regulation Number and Section

§ 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.