Data / Medical devices / China / Jiangsu Hope Biomedical Science&Technology Co.,Ltd.
Jiangsu Hope Biomedical Science&Technology Co.,Ltd.: FDA-registered device maker in Yangzhou Jiangsu, China, 2 510(k) clearances
Jiangsu Hope Biomedical Science&Technology Co.,Ltd. is registered with the FDA (registration 3016168848) in Yangzhou Jiangsu, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 6, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016168848
- Address
- Building 2, No. 88, Muyang Road, High-tech Industrial Development Zone, Yangzhou Jiangsu, China, 225127
- Owner or operator
- Jiangsu Hope Biomedical Science&Technology Co.,Ltd. (10089632)
- Roles
- Manufacturer
- First device listed
- December 23, 2023
- Registered through
- 2026
- Brand names listed
- Disposable Bipolar Forceps, Model: ZKN-1C, ZKN-1X, ZKN-1J, ZKN-2C, ZKN-2X, ZKN-2J, Disposable Bipolar Forceps, Model: ZKN-1CSC, ZKN-1XSC, ZKN-1JSC, ZKN-2CSC, ZKN-2XSC, ZKN-2JSC, Disposable Bipolar Forceps, Model: ZKN-1CWC, ZKN-1XWC, ZKN-1JWC, ZKN-2CWC, ZKN-2XWC, ZKN-2JWC, Disposable Bipolar Forceps, Model: ZKN-1CWZ, ZKN-1XWZ, ZKN-1JWZ, ZKN-2CWZ, ZKN-2XWZ, ZKN-2JWZ, Disposable Bipolar Forceps, Model: ZKN-3C, ZKN-3X, ZKN-3J, ZKN-4C, ZKN-4X, ZKN-4J, Disposable Bipolar Forceps, Model: ZKN-3CSC, ZKN-3XSC, ZKN-3JSC, ZKN-4CSC, ZKN-4XSC, ZKN-4JSC, Disposable Bipolar Forceps, Model: ZKN-3CWC, ZKN-3XWC, ZKN-3JWC, ZKN-4CWC, ZKN-4XWC, ZKN-4JWC, Disposable Bipolar Forceps, Model: ZKN-3CWZ, ZKN-3XWZ, ZKN-3JWZ, ZKN-4CWZ, ZKN-4XWZ, ZKN-4JWZ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | 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 |
|---|---|---|---|---|---|---|
| March 6, 2024 | K232703 | Disposable Bipolar Forceps | GEI | Substantially Equivalent | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | accessdata.fda.gov |
| December 5, 2023 | K231615 | Disposable Endoscopic Bipolar | GEI | Substantially Equivalent | Jiangsu Hope Biomedical Science & Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Instrument, Manual, Surgical, General Use
Updated March 6, 2024. 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.