Nanjing, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 2 | 2026-04-03 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2026-05-29 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | Class II | Gastroenterology, Urology | 1 | 2026-04-24 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2024-03-19 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-29 | K260262 | Injection Needle | FBK | Class II | Gastroenterology, Urology |
| 2026-04-24 | K253832 | Dilation Balloon Catheter | FGE | Class II | Gastroenterology, Urology |
| 2026-04-03 | K254153 | Single-use Video Scope; PB Digital Controller | FBN | Class II | Gastroenterology, Urology |
| 2026-03-19 | K253139 | Disposable Distal Cap | FBN | Class II | Gastroenterology, Urology |
| 2024-03-19 | K233772 | Disposable Dual Action Tissue Closure Device | PKL | Class II | Gastroenterology, Urology |