Xiangtan, CN · 3 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FGB | — | — | — | 1 | 2025-01-22 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2024-02-15 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology, Urology | 1 | 2023-10-16 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-22 | K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | FGB | — | — |
| 2024-02-15 | K231107 | Bronchoscope System | EOQ | Class II | Ear, Nose, Throat |
| 2023-10-16 | K231725 | Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) | GCJ | Class II | Gastroenterology, Urology |