Shanghai, CN · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FAD | Stent, Ureteral | Class II | Gastroenterology, Urology | 1 | 2025-06-18 |
| FDS | — | — | — | 1 | 2025-05-30 |
| KTI | Bronchoscope Accessory | Class II | Ear, Nose, Throat | 1 | 2025-03-04 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology, Urology | 1 | 2024-10-01 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2024-01-11 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2023-09-27 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-06-18 | K243039 | Ureteral Stents (AF-D series) | FAD | Class II | Gastroenterology, Urology |
| 2025-05-30 | K242635 | Endoscopic Distal Attachment (AF-D series) | FDS | — | — |
| 2025-03-04 | K241679 | Disposable Cytology Brush (AF series) | KTI | Class II | Ear, Nose, Throat |
| 2024-10-01 | K241285 | Disposable Endoscope Valves Set (AF series) | ODC | Class II | Gastroenterology, Urology |
| 2024-01-11 | K231633 | Disposable Hemoclip (AF series) | PKL | Class II | Gastroenterology, Urology |
| 2023-09-27 | K230925 | Disposable Injection Needle AF series | FBK | Class II | Gastroenterology, Urology |