HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE
Device Facts
| Record ID | K002021 |
|---|---|
| Device Name | HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE |
| Applicant | Gyrus Ent LLC |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Aug 24, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
