Certus 140 2.45GHz Ablation System
FDA 510(k) K160936 · Neuwave Medical, Inc.
510(k) numberK160936
Submission
- Device name
- Certus 140 2.45GHz Ablation System
- Applicant
- Neuwave Medical, Inc.
Madision, WI, US - Received
- April 4, 2016
- Decision date
- May 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)NEY · Traditional | Hygea Medical Technology Co., Ltd. | 01/31/2024SE |
More from Hygea Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232227 | Ablate-IqJAK · Traditional | 04/04/2024SE |
| K231738 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | 11/16/2023SE |
| K220472 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | 08/11/2022SE |
| K200081 | NEUWAVE Microwave Ablation System and AccessoriesNEY · Traditional | 11/13/2020SE |
| K192427 | Ablation ConfirmationJAK · Special | 10/03/2019SE |
| K173756 | Certus 140 2.45GHz Ablation SystemNEY · Traditional | 10/24/2018SE |
| K171022 | Ablation ConfirmationJAK · Special | 05/09/2017SE |
| K163118 | FLEX Microwave Ablation System and AccessoriesNEY · Traditional | 03/09/2017SE |
| K161285 | Ablation ConfirmationJAK · Special | 06/29/2016SE |
| K150313 | Ablation ConfirmationLLZ · Traditional | 07/09/2015SE |
Questions and answers
When was Certus 140 2.45GHz Ablation System cleared by the FDA?
Certus 140 2.45GHz Ablation System (K160936) received a 510(k) decision of Substantially Equivalent on May 4, 2016, 30 days after the submission was received.
What is the product code of K160936?
The FDA product code is NEY – System, Ablation, Microwave And Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.