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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQO | Unit, Cautery, Thermal, Ac-Powered | 2 | 12 | 3rd Party |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 2 | 24 | 3rd Party |