BWA · Unit, Electrosurgical And Coagulation, With Accessories
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | BWA |
|---|---|
| Device Name | Unit, Electrosurgical And Coagulation, With Accessories |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963305 | ALEXANDER BOX, BATTERY, RECHARGEABLE | Alexander Mfg. Co. | Apr 17, 1997 | SESE |
| K874794 | E600B FOOTSWITCH | Valleylab, Inc. | Dec 14, 1987 | SESE |
| K873809 | EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 | Zimmer Aspen Labs | Nov 20, 1987 | SESE |
Top Applicants
- Alexander Mfg. Co. — 1 clearance
- Valleylab, Inc. — 1 clearance
- Zimmer Aspen Labs — 1 clearance
