Data / Medical devices / China / Sinolinks Medical Innovation, Inc.
Sinolinks Medical Innovation, Inc.: FDA-registered device maker in ChangZhou Jiangsu, China, 2 510(k) clearances
Sinolinks Medical Innovation, Inc. is registered with the FDA (registration 3008383115) in ChangZhou Jiangsu, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008383115
- Address
- NO.10 Ziwei Road, Zhonglou Zone, ChangZhou Jiangsu, China, 213032
- Owner or operator
- Sinolinks Medical Innovation, Inc. (10032341)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 8, 2015
- Registered through
- 2026
- Brand names listed
- Applier, Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Endoscopic Linear Cutter Staplers and Reloads, Disposable Hemorrhoidal Stapler, Disposable Linear Cutter Staplers and Reloads, Disposable Linear Staplers and Reloads, Disposable Skin Staple removers and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Disposable | KDC | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
| Stapler, Skin | QQS | 1 | Complaint file establishment, 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 11, 2025 | K250820 | Disposable Trocars | GCJ | Substantially Equivalent | Sinolinks Medical Innovation, Inc. | accessdata.fda.gov |
| July 5, 2013 | K131511 | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR | GDW | Substantially Equivalent | Changzhou Sinolinks Medical Innovation Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Implantable
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Stapler, Skin
- All makers of Instrument, Surgical, Disposable
- All makers of Applier, Surgical, Clip
Updated July 11, 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.