21 CFR 886.4115 — Unit, Cautery, Thermal, Ac-Powered

Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4115

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
HQOUnit, Cautery, Thermal, Ac-Powered2123rd Party
HQPUnit, Cautery, Thermal, Battery-Powered2243rd Party
Innolitics

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