NEY — System, Ablation, Microwave And Accessories Class II
FDA product code NEY covers "System, Ablation, Microwave And Accessories", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NEY
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253771 | nanjing devin medical technology co | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II | March 2, 2026 |
| K252632 | nanjing dewen medical technology co | Microwave Ablation Device | March 2, 2026 |
| K250718 | emblation limited | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | August 8, 2025 |
| K241827 | canyon medical | Microwave Ablation Generator (KY-2000A, KY-2100A) | September 26, 2024 |
| K241825 | canyon medical | Microwave Ablation Antennas | September 20, 2024 |
| K240480 | varian medical systems | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave | July 19, 2024 |
| K240784 | varian medical systems | Temperature Sensor Probe (ABL-18TP20) | May 29, 2024 |
| K240518 | emblation limited | swiftPro System | April 23, 2024 |
| K233838 | medtronic | Emprint Ablation System with Thermosphere Technology (Overall System Name); Empr | March 28, 2024 |
| K233140 | hygea medical technology co | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact | January 31, 2024 |
| K231738 | neuwave medical | NEUWAVE Microwave Ablation System and Accessories | November 16, 2023 |
| K232241 | betters(suzhou) medical co | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L- | November 13, 2023 |
| K232240 | betters(suzhou) medical co | Microwave Ablation System (BD-GT) | November 13, 2023 |
| K223138 | creo medical | AB1 Electrosurgical Instrument, Creo Electrosurgical System | June 26, 2023 |
| K222388 | emblation | swiftPro System | May 4, 2023 |
| K223581 | angiodynamics | Solero Microwave Tissue Ablation (MTA) System and Accessories | March 27, 2023 |
| K221883 | angiodynamics | Solero Microwave Tissue Ablation (MTA) System and Accessories | March 7, 2023 |
| K223272 | mima-pro scientific | SurBlate Ablation System | February 28, 2023 |
| K221672 | creo medical | Creo Electrosurgical System with NP1 Instrument | February 14, 2023 |
| K220472 | neuwave medical | NEUWAVE Microwave Ablation System and Accessories | August 11, 2022 |