HQQ · Apparatus, Cautery, Radiofrequency, Battery-Powered
Ophthalmic · 21 CFR 886.4100 · Class 2
Overview
| Product Code | HQQ |
|---|---|
| Device Name | Apparatus, Cautery, Radiofrequency, 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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910088 | SCITECH BI-MANUAL ADAPTER CLIPS | Scitech Industries Partnership | Apr 8, 1991 | SESE |
| K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | Mentor O & O, Inc. | Nov 5, 1990 | SESE |
| K881001 | MENTOR WET-FIELD*II COAGULATOR | Mentor O & O, Inc. | May 13, 1988 | SESE |
Top Applicants
- Mentor O & O, Inc. — 2 clearances
- Scitech Industries Partnership — 1 clearance
