NEY · System, Ablation, Microwave And Accessories
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | NEY |
|---|---|
| Device Name | System, Ablation, Microwave And 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 68)
Showing 20 most recent of 68 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253771 | 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 | Microwave Ablation Device | Nanjing Dewen Medical Technology Co., Ltd. | Mar 2, 2026 | SESE |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | Emblation Limited | Aug 8, 2025 | SESE |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A) | Canyon Medical, Inc. | Sep 26, 2024 | SESE |
| K241825 | Microwave Ablation Antennas | Canyon Medical, Inc. | Sep 20, 2024 | SESE |
| K240480 | 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 | Temperature Sensor Probe (ABL-18TP20) | Varian Medical Systems, Inc. | May 29, 2024 | SESE |
| K240518 | swiftPro System | Emblation Limited | Apr 23, 2024 | SESE |
| K233838 | 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 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | Hygea Medical Technology Co., Ltd. | Jan 31, 2024 | SESE |
| K231738 | NEUWAVE Microwave Ablation System and Accessories | Neuwave Medical, Inc. | Nov 16, 2023 | SESE |
| K232241 | 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 | Microwave Ablation System (BD-GT) | Betters(Suzhou) Medical Co., Ltd. | Nov 13, 2023 | SESE |
| K223138 | AB1 Electrosurgical Instrument, Creo Electrosurgical System | Creo Medical, Ltd. | Jun 26, 2023 | SESE |
| K222388 | swiftPro System | Emblation , Ltd. | May 4, 2023 | SESE |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | Mar 27, 2023 | SESE |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | AngioDynamics, Inc. | Mar 7, 2023 | SESE |
| K223272 | SurBlate Ablation System | Mima-Pro Scientific, Inc. | Feb 28, 2023 | SESE |
| K221672 | Creo Electrosurgical System with NP1 Instrument | Creo Medical, Ltd. | Feb 14, 2023 | SESE |
| K220472 | 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
