GEI · Electrosurgical, Cutting & Coagulation & Accessories
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | GEI |
|---|---|
| Device Name | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System | Medtronic Sofamor Danek USA, Inc. | Jun 5, 2026 | SESE |
| K253918 | Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) | F Care Systems USA, LLC | Jun 2, 2026 | SESE |
| K253803 | MILAN System | Lumenis Be, Ltd. | Jun 2, 2026 | SESE |
| K261202 | ENTire IRE System | Entire Medical , Ltd. | May 29, 2026 | SESE |
| K252833 | VIVA combo RF System | Starmed Co., Ltd. | May 26, 2026 | SESE |
| K253134 | LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) | Lagis Enterprise Co., Ltd. | May 20, 2026 | SESE |
| K260522 | RhinAer+ Stylus | Aerin Medical, Inc. | May 18, 2026 | SESE |
| K253917 | ARION ARC System | Plasma Surgical, Inc. | Apr 10, 2026 | SESE |
| K253777 | Ascblue (8010) | Ascblue Corporation | Apr 10, 2026 | SESE |
| K260466 | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | Apr 7, 2026 | SESE |
| K260397 | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | Apr 6, 2026 | SESE |
| K253405 | Prana System | Prana Surgical | Apr 1, 2026 | SESE |
| K254122 | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | Mar 30, 2026 | SESE |
| K260255 | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | Mar 27, 2026 | SESE |
| K253680 | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | Mar 25, 2026 | SESE |
| K253750 | BTL-785NEH | BTL Industries, Inc. | Mar 17, 2026 | SESE |
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | Mar 2, 2026 | SESE |
| K260287 | SP Electrocautery Device (SP20) | Single Pass, Inc. | Feb 24, 2026 | SESE |
| K251813 | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | Feb 11, 2026 | SESE |
| K251836 | 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
