DWG · Electrosurgical Device
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | DWG |
|---|---|
| Device Name | Electrosurgical Device |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942823 | MAHE INSTRUMENTS | Mahe Intl., Inc. | Dec 5, 1994 | SESE |
| K932345 | TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE | Conmedcorp | Apr 12, 1994 | SESE |
| K931215 | HAND-TROL S | Aspen Labs | Mar 28, 1994 | SESE |
| K925708 | DISPOSABLE ELECTROSURGERY BALL ELECTRODE | Beacon Laboratories, Inc. | Apr 20, 1993 | SESE |
Top Applicants
- Aspen Labs — 1 clearance
- Beacon Laboratories, Inc. — 1 clearance
- Conmedcorp — 1 clearance
- Mahe Intl., Inc. — 1 clearance
