ODR · Electrosurgical Patient Return Electrode
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | ODR |
|---|---|
| Device Name | Electrosurgical Patient Return Electrode |
| 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 |
|---|---|---|---|---|
| K160366 | Electrosurgical disposable grounding pads | Top-Rank Health Care Co., Ltd. | Aug 19, 2016 | SESE |
| K121268 | WANDY DISPERSVIE ELECTRODE | Bio-Med USA, Inc. | Dec 20, 2012 | SESE |
| K082204 | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | Ventlab Corp. | Aug 13, 2008 | SESE |
Top Applicants
- Bio-Med USA, Inc. — 1 clearance
- Top-Rank Health Care Co., Ltd. — 1 clearance
- Ventlab Corp. — 1 clearance
