HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE

• K Number: K002021
• Device Name: HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
• Manufacturer: GYRUS ENT L.L.C.
• Date Cleared: 2000-08-24 ( 52 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: General & Plastic Surgery
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K021777 , K183009

Intended Use

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Device Description

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AI/ML Overview

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Summary

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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.