Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → ODR — Electrosurgical Patient Return Electrode

# ODR · Electrosurgical Patient Return Electrode

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ODR

## Overview

- **Product Code:** ODR
- **Device Name:** Electrosurgical Patient Return Electrode
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ODR/K160366.md) | Electrosurgical disposable grounding pads | Top-Rank Health Care Co., Ltd. | Aug 19, 2016 | SESE |
| [K121268](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ODR/K121268.md) | WANDY DISPERSVIE ELECTRODE | Bio-Med USA, Inc. | Dec 20, 2012 | SESE |
| [K082204](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ODR/K082204.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ODR](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ODR)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com