Data / Medical devices / China / Betters(Suzhou) Medical Co., LTD
Betters(Suzhou) Medical Co., LTD: FDA-registered device maker in Suzhou Jiangsu, China, 2 510(k) clearances
Betters(Suzhou) Medical Co., LTD is registered with the FDA (registration 3030234858) in Suzhou Jiangsu, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 13, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3030234858
- Address
- Fifth Floor, Building 7, Taicang Biological Port, 52 Yingang Road Taicang Port Economic and Technological Development Zone, Suzhou, Suzhou Jiangsu, China, 215412
- Owner or operator
- Betters(Suzhou) Medical Co., LTD (10089332)
- Roles
- Manufacturer
- First device listed
- November 29, 2023
- Registered through
- 2026
- Brand names listed
- Disposable Microwave Ablation Needle, Microwave Ablation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 13, 2023 | K232241 | Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) | NEY | Substantially Equivalent | Betters(Suzhou) Medical Co., Ltd. | accessdata.fda.gov |
| November 13, 2023 | K232240 | Microwave Ablation System (BD-GT) | NEY | Substantially Equivalent | Betters(Suzhou) Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.