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K Number
K000893
Device Name
AC POWERED THERMAL CAUTERY UNIT
Manufacturer
STARION INSTRUMENTS
Date Cleared
2000-06-14

(86 days)

Product Code
HQO
Regulation Number
886.4115
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.