21 CFR 886.4100 — Apparatus, Cautery, Radiofrequency, Battery-Powered
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4100
Identification
A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQQ | Apparatus, Cautery, Radiofrequency, Battery-Powered | 2 | 3 | 3rd Party |
| HQR | Apparatus, Cautery, Radiofrequency, Ac-Powered | 2 | 11 | 3rd Party |
| NCR | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered | 2 | 3 | 3rd Party |
| PUL | Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered | 2 | 4 |