REPLACE-A-TIP RECHARG. LOW TEMP.
Device Facts
| Record ID | K841325 |
|---|---|
| Device Name | REPLACE-A-TIP RECHARG. LOW TEMP. |
| Applicant | Suncoast Medical Manufacturers, Inc. |
| Product Code | HQP · Ophthalmic |
| Decision Date | May 9, 1984 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4115 |
| Device Class | Class 2 |
Regulatory Classification
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.
