PDG · Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | PDG |
|---|---|
| Device Name | Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator. |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123212 | ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS | Ethicon Endo-Surgery, LLC | Mar 8, 2013 | SESE |
Top Applicants
- Ethicon Endo-Surgery, LLC — 1 clearance
