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-staging.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 2316)

Showing 20 most recent of 2316 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254185](/device/K254185.md) | Potenza Prime | Jeisys Medical Incorporated | Sep 11, 2026 | SESE |
| [K262364](/device/K262364.md) | Ellian Enigma RF Device | Ellian Corp | Sep 2, 2026 | SESE |
| [K253859](/device/K253859.md) | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | Aug 27, 2026 | SESE |
| [K252535](/device/K252535.md) | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | Aug 25, 2026 | SESE |
| [K261179](/device/K261179.md) | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | Jul 22, 2026 | SESE |
| [K253504](/device/K253504.md) | Volnewmer™ | Classys, Inc. | Jul 13, 2026 | SESE |
| [K254056](/device/K254056.md) | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | Jul 1, 2026 | SESE |
| [K253484](/device/K253484.md) | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | Jun 29, 2026 | SESE |
| [K251492](/device/K251492.md) | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | Jun 29, 2026 | SESE |
| [K260636](/device/K260636.md) | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | Jun 18, 2026 | SESE |
| [K253634](/device/K253634.md) | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | Jun 17, 2026 | SESE |
| [K261833](/device/K261833.md) | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | Jun 16, 2026 | SESE |
| [K253165](/device/K253165.md) | LAP-iX2N | Sejong Medical Co., Ltd. | Jun 9, 2026 | SESE |
| [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 |

## 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-staging.innolitics.com/productcode/GEI](https://fda-staging.innolitics.com/productcode/GEI)

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