MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
Device Facts
| Record ID | K903878 |
|---|---|
| Device Name | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT |
| Applicant | Mentor O & O, Inc. |
| Product Code | HQQ · Ophthalmic |
| Decision Date | Nov 5, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4100 |
| Device Class | Class 2 |
Regulatory Classification
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.