Hangzhou, CN · 9 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OCX | — | — | — | 2 | 2023-11-21 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology, Urology | 1 | 2026-03-06 |
| FAD | Stent, Ureteral | Class II | Gastroenterology, Urology | 1 | 2026-02-20 |
| FDX | Endoscopic Cytology Brush | Class II | Gastroenterology, Urology | 1 | 2022-07-28 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2022-05-27 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2022-05-25 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2022-02-23 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Class II | Gastroenterology, Urology | 1 | 2020-03-27 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-06 | K253132 | Single use stone retrieval balloons | FGE | Class II | Gastroenterology, Urology |
| 2026-02-20 | K251890 | Disposable Ureteral Stents | FAD | Class II | Gastroenterology, Urology |
| 2023-11-21 | K230773 | Endoscopy Irrigation Tubing | OCX | — | — |
| 2023-09-08 | K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | OCX | — | — |
| 2022-07-28 | K220063 | Single Use Cytology Brush | FDX | Class II | Gastroenterology, Urology |
| 2022-05-27 | K212669 | Single Use Hemoclip | PKL | Class II | Gastroenterology, Urology |
| 2022-05-25 | K220065 | Single Use Ureteral Access Sheath | FED | Class II | Gastroenterology, Urology |
| 2022-02-23 | K212668 | Sclerotherapy Needle | FBK | Class II | Gastroenterology, Urology |
| 2020-03-27 | K191900 | Single Use Grasping Forceps | OCZ | Class II | Gastroenterology, Urology |