BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM
Device Facts
| Record ID | K924188 |
|---|---|
| Device Name | BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM |
| Applicant | Valley Forge Scientific Corp. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Dec 10, 1992 |
| 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.