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/submissions/SU/subpart-e%E2%80%94surgical-devices/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 2296) Showing 20 most recent of 2296 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253917](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K253917.md) | ARION ARC System | Plasma Surgical, Inc. | Apr 10, 2026 | SESE | | [K253777](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K253777.md) | Ascblue (8010) | Ascblue Corporation | Apr 10, 2026 | SESE | | [K260466](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K260466.md) | Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) | Zhejiang shuyou Surgical Instrument Co., Ltd. | Apr 7, 2026 | SESE | | [K260397](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K260397.md) | SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) | Hironic Co., Ltd. | Apr 6, 2026 | SESE | | [K253405](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K253405.md) | Prana System | Prana Surgical | Apr 1, 2026 | SESE | | [K254122](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K254122.md) | FLOW FLEXTEND Wand (72290039) | ArthroCare Corporation | Mar 30, 2026 | SESE | | [K260255](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K260255.md) | AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001) | Aventix Medical, Inc. | Mar 27, 2026 | SESE | | [K253680](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K253680.md) | LYNX COBLATION Laryngeal Wand (72290254) | ArthroCare Corporation | Mar 25, 2026 | SESE | | [K253750](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K253750.md) | BTL-785NEH | BTL Industries, Inc. | Mar 17, 2026 | SESE | | [K252487](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K252487.md) | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) | Gyrus Acmi, Inc. | Mar 2, 2026 | SESE | | [K260287](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K260287.md) | SP Electrocautery Device (SP20) | Single Pass, Inc. | Feb 24, 2026 | SESE | | [K251813](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K251813.md) | CURIS II RF Generator (REF 360100-05) | Sutter Medizintechnik GmbH | Feb 11, 2026 | SESE | | [K251836](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K251836.md) | Dermatrix Duo | Shenzhen Gsd Technology Co., Ltd. | Feb 6, 2026 | SESE | | [K254290](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K254290.md) | ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) | Shenzhen Peninsula Medical Group | Jan 30, 2026 | SESE | | [K254220](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K254220.md) | Reusable 3 Button Fingerswitch Wand | Soniquence, LLC | Jan 27, 2026 | SESE | | [K251435](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K251435.md) | InbellaIgnite RF System | Inbella Medical, Inc. | Jan 27, 2026 | SESE | | [K251254](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K251254.md) | Ignite RF System | InMode , Ltd. | Jan 15, 2026 | SESE | | [K251996](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K251996.md) | ENTire IRE System | Entire Medical , Ltd. | Jan 14, 2026 | SESE | | [K251988](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K251988.md) | Boston iFace (Boston iFace) | Boston Aesthetics, Inc. | Jan 12, 2026 | SESE | | [K253915](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K253915.md) | MOVIVA® Hybrid Ablation Probe | Erbe Elektromedizin GmbH | Dec 18, 2025 | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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