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) → DWG — Electrosurgical Device

# DWG · Electrosurgical Device

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

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

## Overview

- **Product Code:** DWG
- **Device Name:** Electrosurgical Device
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K942823](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/DWG/K942823.md) | MAHE INSTRUMENTS | Mahe Intl., Inc. | Dec 5, 1994 | SESE |
| [K932345](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/DWG/K932345.md) | TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE | Conmedcorp | Apr 12, 1994 | SESE |
| [K931215](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/DWG/K931215.md) | HAND-TROL S | Aspen Labs | Mar 28, 1994 | SESE |
| [K925708](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/DWG/K925708.md) | 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

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

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