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) → NEY — System, Ablation, Microwave And Accessories # NEY · System, Ablation, Microwave And Accessories _General, Plastic Surgery · 21 CFR 878.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY ## Overview - **Product Code:** NEY - **Device Name:** System, Ablation, Microwave And 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 68) Showing 20 most recent of 68 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253771](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K253771.md) | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) | Nanjing Devin Medical Technology Co., Ltd. | Mar 2, 2026 | SESE | | [K252632](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K252632.md) | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | Mar 2, 2026 | SESE | | [K250718](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K250718.md) | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | Aug 8, 2025 | SESE | | [K241827](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K241827.md) | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | Sep 26, 2024 | SESE | | [K241825](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K241825.md) | Microwave Ablation Antennas | Canyon Medical, Inc. | Sep 20, 2024 | SESE | | [K240480](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K240480.md) | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | Varian Medical Systems, Inc. | Jul 19, 2024 | SESE | | [K240784](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K240784.md) | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | May 29, 2024 | SESE | | [K240518](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K240518.md) | swiftPro™ System | Emblation Limited | Apr 23, 2024 | SESE | | [K233838](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K233838.md) | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien™ Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien™ Remote Temperature Probe (RTP20); Covidien™ Remote Temperature Probe, Bulk (RTP20B) | Medtronic, Inc. | Mar 28, 2024 | SESE | | [K233140](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K233140.md) | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. | Jan 31, 2024 | SESE | | [K231738](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K231738.md) | NEUWAVE™ Microwave Ablation System and Accessories | Neuwave Medical, Inc. | Nov 16, 2023 | SESE | | [K232241](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K232241.md) | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | Betters(Suzhou) Medical Co., Ltd. | Nov 13, 2023 | SESE | | [K232240](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K232240.md) | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. | Nov 13, 2023 | SESE | | [K223138](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K223138.md) | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | Jun 26, 2023 | SESE | | [K222388](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K222388.md) | swiftPro System | Emblation , Ltd. | May 4, 2023 | SESE | | [K223581](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K223581.md) | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | Mar 27, 2023 | SESE | | [K221883](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K221883.md) | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | Mar 7, 2023 | SESE | | [K223272](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K223272.md) | SurBlate Ablation System | Mima-Pro Scientific, Inc. | Feb 28, 2023 | SESE | | [K221672](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K221672.md) | Creo Electrosurgical System with NP1 Instrument | Creo Medical, Ltd. | Feb 14, 2023 | SESE | | [K220472](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY/K220472.md) | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | Aug 11, 2022 | SESE | ## Top Applicants - Neuwave Medical, Inc. — 10 clearances - Covidien, LLC — 5 clearances - AngioDynamics, Inc. — 5 clearances - Creo Medical, Ltd. — 4 clearances - Miramar Labs, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NEY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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