Shenzhen, CN · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| FBN | Choledochoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 2 | 2025-01-21 |
| BTA | — | — | — | 1 | 2026-05-14 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 1 | 2025-07-08 |
| FGB | — | — | — | 1 | 2024-05-10 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2024-04-26 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 1 | 2023-11-13 |
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2023-04-11 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-14 | K260892 | Suction Pump (SU-90) | BTA | — | — |
| 2025-07-08 | K250695 | Single-use Ureteral Access Sheath | FED | Class II | Gastroenterology, Urology |
| 2025-01-21 | K241444 | Biliary Pancreaticobiliary Scope System | FBN | Class II | Gastroenterology, Urology |
| 2024-05-10 | K240374 | Ureterorenoscope System | FGB | — | — |
| 2024-04-26 | K232435 | Rhinolaryngoscope system | EOB | Class II | Ear, Nose, Throat |
| 2024-03-06 | K231497 | Choledochoscope System | FBN | Class II | Gastroenterology, Urology |
| 2023-11-13 | K231118 | Cystoscope System | FAJ | Class II | Gastroenterology, Urology |
| 2023-04-11 | K222910 | Bronchoscope System | EOQ | Class II | Ear, Nose, Throat |