Hygea
Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities.…
Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.
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 | Hygea Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | NEY |
| Device type | System, Ablation, Microwave And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K233140 |
| Record published | 2025-09-08 |
| Record revised | 2026-05-22 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Exact HC-1514150U | In distribution | |
| Exact HP-1805080U | In distribution | |
| Exact HC-1814200U | In distribution | |
| Ease TSL08A | In distribution | |
| Exceed S10U | In distribution | |
| Ease TML15A | In distribution | |
| Exact HC-1514200U | In distribution | |
| Exact HC-1614200U | In distribution | |
| Exact HP-1507200U | In distribution | |
| Exact HC-1414250U | In distribution | |
| Exact HS-1425200U | In distribution | |
| Exact HT-1414200U | In distribution | |
| Exact HP-1605100U | In distribution | |
| Exact HS-1425150U | In distribution | |
| Exact HP-1512200U | In distribution | |
| Exact HC-1614150U | In distribution | |
| Exact HC-1814100U | In distribution | |
| Exact HC-1814150U | In distribution |
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 |
| Avecure | MedWaves, Inc | 17 |
| Certus® 140 | Neuwave Medical, 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 |
|---|---|
| K233140 | 2024-01-31 |
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.