Shenzhen, CN · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LJE | Catheter, Nephrostomy | Unclassified | Unknown | 1 | 2025-07-03 |
| FAD | Stent, Ureteral | Class II | Gastroenterology, Urology | 1 | 2025-05-14 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2025-04-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-07-03 | K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | LJE | Unclassified | Unknown |
| 2025-05-14 | K243830 | Disposable ureteral stent | FAD | Class II | Gastroenterology, Urology |
| 2025-04-11 | K243710 | Disposable ureteral access sheath | FED | Class II | Gastroenterology, Urology |