BIPOLAR ELECTROSURGICAL PENCIL
Device Facts
| Record ID | K943031 |
|---|---|
| Device Name | BIPOLAR ELECTROSURGICAL PENCIL |
| Applicant | Boston Surgical Products, Inc. |
| Product Code | HQO · Ophthalmic |
| Decision Date | Sep 23, 1994 |
| 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.
