BIPOLAR PENCIL, MODEL 3901-002, 3900-002
Device Facts
| Record ID | K010487 |
|---|---|
| Device Name | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 |
| Applicant | Medtronic PS Medical |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | May 3, 2001 |
| Decision | SESE |
| Submission Type | Abbreviated |
| 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.
