Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
FDA 510(k) K233140 · Hygea Medical Technology Co., Ltd.
510(k) numberK233140
Submission
- Device name
- Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)
- Applicant
- Hygea Medical Technology Co., Ltd.
Beijing, CN - Received
- September 27, 2023
- Decision date
- January 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEY – System, Ablation, Microwave And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code NEY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253771 | Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…NEY · Traditional | Nanjing Devin Medical Technology Co., Ltd. | 03/02/2026SE |
| K252632 | Microwave Ablation DeviceNEY · Traditional | Nanjing Dewen Medical Technology Co., Ltd. | 03/02/2026SE |
| K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS)NEY · Traditional | Emblation Limited | 08/08/2025SE |
| K241827 | Microwave Ablation Generator (KY-2000A, KY-2100A)NEY · Traditional | Canyon Medical, Inc. | 09/26/2024SE |
| K241825 | Microwave Ablation AntennasNEY · Traditional | Canyon Medical, Inc. | 09/20/2024SE |
| K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation…NEY · Traditional | Varian Medical Systems, Inc. | 07/19/2024SE |
| K240784 | Temperature Sensor Probe (ABL-18TP20)NEY · Traditional | Varian Medical Systems, Inc. | 05/29/2024SE |
| K240518 | swiftPro SystemNEY · Traditional | Emblation Limited | 04/23/2024SE |
| K233838 | Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…NEY · Special | Medtronic, Inc. | 03/28/2024SE |
| K231738 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | Neuwave Medical, Inc. | 11/16/2023SE |
More from Neuwave Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243042 | Co-Ablation System with Sterile Co-Ablation ProbeGEH · Traditional | 01/29/2025SE |
Questions and answers
When was Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) cleared by the FDA?
Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) (K233140) received a 510(k) decision of Substantially Equivalent on January 31, 2024, 126 days after the submission was received.
What is the product code of K233140?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.