Data / Medical devices / China / Zhejiang Curaway Medical Technology Co., Ltd
Zhejiang Curaway Medical Technology Co., Ltd: FDA-registered device maker in Hangzhou Zhejiang, China, 6 510(k) clearances
Zhejiang Curaway Medical Technology Co., Ltd is registered with the FDA (registration 3017448139) in Hangzhou Zhejiang, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 22, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3017448139
- Address
- Room 106, Building 1, No.600, 21st Avenue, Baiyang Sub-district, Qiantang New District, Hangzhou Zhejiang, China, 310018
- Owner or operator
- Zhejiang CuraWay Medical Technology Co., Ltd. (10076584)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- July 24, 2020
- Registered through
- 2026
- Brand names listed
- Automatic Core Biopsy Instrument, Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, Disposable Coaxial Biopsy Needle, Bone Marrow Biopsy Needle, Breast Lesion Localization Wire, Soft Tissue Localization Wire, Disposable Biopsy Needle, Disposable Needle Guider, Probe Spacer, Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter, Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Compression | MHW | 1 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Guide, Needle, Surgical | GDF | 1 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Low Energy Direct Current Thermal Ablation System | OAB | 2 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Foreign private label distributor, 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 |
|---|---|---|---|---|---|---|
| July 22, 2025 | K244018 | Disposable Biopsy Needle | KNW | Substantially Equivalent | Zhejiang Curaway Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 24, 2025 | K242322 | Bone Marrow Biopsy Needle | KNW | Substantially Equivalent | Zhejiang Curaway Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 24, 2025 | K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle | KNW | Substantially Equivalent | Zhejiang Curaway Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 11, 2024 | K240758 | Radiofrequency Generator System, Cura RF Electrode | GEI | Substantially Equivalent | Zhejiang Curaway Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 30, 2024 | K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter | GEI | Substantially Equivalent | Zhejiang Curaway Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 8, 2023 | K222001 | Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | OAB | Substantially Equivalent | Zhejiang Curaway Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Tape And Bandage, Adhesive
- All makers of Instrument, Biopsy
- All makers of Guide, Surgical, Instrument
- All makers of Guide, Needle, Surgical
- All makers of Dressing, Compression
Updated July 22, 2025. 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.