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) → GEI — Electrosurgical, Cutting & Coagulation & Accessories

# GEI · Electrosurgical, Cutting & Coagulation & Accessories

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

**Canonical URL:** https://fda.innolitics.com/productcode/GEI

## Overview

- **Product Code:** GEI
- **Device Name:** Electrosurgical, Cutting & Coagulation & 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 (20 of 2303)

Showing 20 most recent of 2303 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253656](/device/K253656.md) | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | Jun 5, 2026 | SESE |
| [K253918](/device/K253918.md) | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | Jun 2, 2026 | SESE |
| [K253803](/device/K253803.md) | MILAN System | Lumenis Be, Ltd. | Jun 2, 2026 | SESE |
| [K261202](/device/K261202.md) | ENTire IRE System | Entire Medical , Ltd. | May 29, 2026 | SESE |
| [K252833](/device/K252833.md) | VIVA combo RF System | Starmed Co., Ltd. | May 26, 2026 | SESE |
| [K253134](/device/K253134.md) | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | May 20, 2026 | SESE |
| [K260522](/device/K260522.md) | RhinAer+ Stylus | Aerin Medical, Inc. | May 18, 2026 | SESE |
| [K253917](/device/K253917.md) | ARION ARC System | Plasma Surgical, Inc. | Apr 10, 2026 | SESE |
| [K253777](/device/K253777.md) | Ascblue (8010) | Ascblue Corporation | Apr 10, 2026 | SESE |
| [K260466](/device/K260466.md) | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | Apr 7, 2026 | SESE |
| [K260397](/device/K260397.md) | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | Apr 6, 2026 | SESE |
| [K253405](/device/K253405.md) | Prana System | Prana Surgical | Apr 1, 2026 | SESE |
| [K254122](/device/K254122.md) | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | Mar 30, 2026 | SESE |
| [K260255](/device/K260255.md) | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | Mar 27, 2026 | SESE |
| [K253680](/device/K253680.md) | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | Mar 25, 2026 | SESE |
| [K253750](/device/K253750.md) | BTL-785NEH | BTL Industries, Inc. | Mar 17, 2026 | SESE |
| [K252487](/device/K252487.md) | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | Mar 2, 2026 | SESE |
| [K260287](/device/K260287.md) | SP Electrocautery Device (SP20) | Single Pass, Inc. | Feb 24, 2026 | SESE |
| [K251813](/device/K251813.md) | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | Feb 11, 2026 | SESE |
| [K251836](/device/K251836.md) | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | Feb 6, 2026 | SESE |

## Top Applicants

- Arthrocare Corp. — 64 clearances
- Valleylab, Inc. — 60 clearances
- Conmedcorp — 43 clearances
- Megadyne Medical Products, Inc. — 32 clearances
- Aaron Medical Industries — 27 clearances

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**Source:** [https://fda.innolitics.com/productcode/GEI](https://fda.innolitics.com/productcode/GEI)

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