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) → BWA — Unit, Electrosurgical And Coagulation, With Accessories

# BWA · Unit, Electrosurgical And Coagulation, With Accessories

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

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

## Overview

- **Product Code:** BWA
- **Device Name:** Unit, Electrosurgical And Coagulation, With Accessories
- **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 |
| --- | --- | --- | --- | --- |
| [K963305](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWA/K963305.md) | ALEXANDER BOX, BATTERY, RECHARGEABLE | Alexander Mfg. Co. | Apr 17, 1997 | SESE |
| [K874794](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWA/K874794.md) | E600B FOOTSWITCH | Valleylab, Inc. | Dec 14, 1987 | SESE |
| [K873809](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/BWA/K873809.md) | EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001 | Zimmer Aspen Labs | Nov 20, 1987 | SESE |

## Top Applicants

- Alexander Mfg. Co. — 1 clearance
- Valleylab, Inc. — 1 clearance
- Zimmer Aspen Labs — 1 clearance

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

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