Shanghai, CN · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 2 | 2025-03-07 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 1 | 2026-01-30 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2024-10-22 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology, Urology | 1 | 2023-11-22 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 1 | 2022-02-22 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-30 | K252457 | Disposable Distal End Tape Hood | FDF | Class II | Gastroenterology, Urology |
| 2025-03-07 | K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | FBN | Class II | Gastroenterology, Urology |
| 2024-10-22 | K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | FET | Class II | Gastroenterology, Urology |
| 2023-11-22 | K222499 | Disposable Endoscope Valves Kit | ODC | Class II | Gastroenterology, Urology |
| 2023-04-20 | K222261 | Flexible Video-Choledochoscope System | FBN | Class II | Gastroenterology, Urology |
| 2022-02-22 | K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | FGB | Class II | Gastroenterology, Urology |