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) → PDG — Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

# PDG · Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.

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

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

## Overview

- **Product Code:** PDG
- **Device Name:** Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K123212](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PDG/K123212.md) | ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS | Ethicon Endo-Surgery, LLC | Mar 8, 2013 | SESE |

## Top Applicants

- Ethicon Endo-Surgery, LLC — 1 clearance

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

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