Hangzhou, CN · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Class II | Gastroenterology, Urology | 1 | 2026-05-08 |
| LQR | Dislodger, Stone, Biliary | Class II | Gastroenterology, Urology | 1 | 2026-04-03 |
| PKL | Hemostatic Metal Clip For The Gi Tract | Class II | Gastroenterology, Urology | 1 | 2024-01-26 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2023-11-09 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Class II | Gastroenterology, Urology | 1 | 2023-11-07 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-08 | K253013 | Disposable Stone Retrieval Balloon Catheter | GCA | Class II | Gastroenterology, Urology |
| 2026-04-03 | K253056 | Disposable Stone Extraction Basket | LQR | Class II | Gastroenterology, Urology |
| 2024-01-26 | K232450 | Disposable Hemostatic Clips | PKL | Class II | Gastroenterology, Urology |
| 2023-11-09 | K232442 | Disposable Endoscope Injection Needles | FBK | Class II | Gastroenterology, Urology |
| 2023-11-07 | K232476 | Disposable Sphincterotome | KNS | Class II | Gastroenterology, Urology |