STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

• K Number: K002547
• Device Name: STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR
• Manufacturer: STARION INSTRUMENTS
• Date Cleared: 2000-10-20 ( 64 days)
• Product Code: HQP
• Regulation Number: 886.4115
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: K062257

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

§ 886.4115 Thermal cautery unit.

(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.