NCR · Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
Ophthalmic · 21 CFR 886.4100 · Class 2
Overview
| Product Code | NCR |
|---|---|
| Device Name | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered |
| Regulation | 21 CFR 886.4100 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050933 | FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 | Medisurg , Ltd. | Dec 9, 2005 | SESE |
| K041019 | THE FUGO BLADE FOR GLAUCOMA | Medisurg , Ltd. | Oct 8, 2004 | SESE |
| K001498 | THE FUGO BLADE | Medisurg , Ltd. | Aug 10, 2000 | SESE |
Top Applicants
- Medisurg , Ltd. — 3 clearances
