FDA product code NEY: System, Ablation, Microwave And Accessories
NEY is the FDA product code for system, ablation, microwave and accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 68 510(k) submissions under NEY, 20 in the last five years, from 34 different applicants. The average 510(k) review took 177 days (median 150); 132 days on average over the last three years. FDA has posted 27 recalls for NEY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Ablation, Microwave And Accessories |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NEY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 161 |
| 2018 | 3 | 146 |
| 2019 | 2 | 214 |
| 2020 | 7 | 214 |
| 2021 | 4 | 317 |
| 2022 | 1 | 174 |
| 2023 | 9 | 183 |
| 2024 | 7 | 100 |
| 2025 | 1 | 151 |
| 2026 | 2 | 145 |
Compare with all 510(k) review times · Search every NEY clearance
Top NEY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neuwave Medical, Inc. | 10 | 2023-11-16 |
| AngioDynamics, Inc. | 5 | 2023-03-27 |
| Covidien, LLC | 5 | 2020-12-17 |
| Creo Medical, Ltd. | 4 | 2023-06-26 |
| Miramar Labs, Inc. | 3 | 2018-03-15 |
29 more applicants have NEY clearances. See the full list in Caduvo.
Most recent NEY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253771 | Nanjing Devin Medical Technology Co., Ltd. | 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) | 2026-03-02 | 96 |
| K252632 | Nanjing Dewen Medical Technology Co., Ltd. | Microwave Ablation Device | 2026-03-02 | 194 |
| K250718 | Emblation Limited | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | 2025-08-08 | 151 |
| K241827 | Canyon Medical, Inc. | Microwave Ablation Generator (KY-2000A, KY-2100A) | 2024-09-26 | 94 |
| K241825 | Canyon Medical, Inc. | Microwave Ablation Antennas | 2024-09-20 | 88 |
Recalls for NEY devices
27 product recalls in 8 recall events; 1 initiated in the last five years and 10 still open. Most recent: 2022-11-23.
| Year | Recalls |
|---|---|
| 2017 | 12 |
| 2018 | 3 |
| 2019 | 5 |
| 2021 | 5 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code NEY?
NEY is the FDA product code for system, ablation, microwave and accessories. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is NEY?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEY?
Across 68 cleared submissions the average was 177 days from receipt to decision (median 150).
Which companies have the most NEY clearances?
Neuwave Medical, Inc. (10); AngioDynamics, Inc. (5); Covidien, LLC (5); Creo Medical, Ltd. (4); Miramar Labs, Inc. (3).
Have NEY devices been recalled?
Yes: 27 product recalls across 8 recall events; the most recent began 2022-11-23.
Next steps
- Run an FDA pathway report with predicate devices for product code NEY
- Run a recall and safety report across every NEY manufacturer
- Watch product code NEY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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