Certus® 140
SR25cm-13ga CertusSR Ablation Probe, 25 cm, 13 ga
10manufacturers in China registered for this device type
17catalogue numbers in this listing
10510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Betters(Suzhou) Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 1 |
| Nanjing Devin Medical Technology Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| ECO Medical Technology (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 1 |
| Mima-PRO (NAN Tong) Scientific Inc. | Nantong | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Neuwave Medical, Inc., United States |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-18 |
| Record revised | 2023-10-18 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -40 to 55 °C |
| Distribution end date | 2021-05-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn | |
| 2.45 GHz Ablation System | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microwave Ablation Antennas | Canyon Medical Inc. | 66 |
| Neuwave | Neuwave Medical, Inc. | 25 |
| ECO Disposable microwave therapeutic antenna | ECO Medical Technology (Nanjing) Co., Ltd. | 21 |
| Hygea | Hygea Medical Technology Co., Ltd. | 18 |
| Avecure | MedWaves, Inc | 17 |
| Emprint | Covidien LP | 14 |
| Betters (Suzhou)Medical Co., Ltd. | Betters(Suzhou) Medical Co., Ltd. | 11 |
| Emprint SX | Covidien LP | 11 |
| Mima-Pro | Mima-PRO (NAN Tong) Scientific Inc. | 10 |
| Dophi | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 9 |
| Evident | Covidien LP | 8 |
| SynchroWave Antenna Kit | Varian Medical Systems, Inc | 6 |
Showing 12 of 55. All products under System, Ablation, Microwave And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231738 | 2023-11-16 |
| K220472 | 2022-08-11 |
| K200081 | 2020-11-13 |
| K173756 | 2018-10-24 |
| K163118 | 2017-03-09 |
| K160936 | 2016-05-04 |
| K130399 | 2013-07-18 |
| K122217 | 2012-12-19 |
| K113237 | 2012-01-04 |
| K100744 | 2010-10-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.