| 2025-07-25 |
K250232 |
Vathin® Video Bronchoscope System |
EOQ |
Class II |
Ear, Nose, Throat |
| 2025-07-03 |
K251599 |
Single-use Ureteral Access Sheath |
FED |
Class II |
Gastroenterology, Urology |
| 2025-05-06 |
K250785 |
Single-use Flexible Ureteroscope |
FGB |
— |
— |
| 2025-01-29 |
K243117 |
Digital Video Processor |
FGB |
— |
— |
| 2025-01-16 |
K242416 |
Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL |
EOQ |
Class II |
Ear, Nose, Throat |
| 2024-12-18 |
K242535 |
Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) |
FAJ |
Class II |
Gastroenterology, Urology |
| 2024-10-29 |
K241612 |
Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) |
EOQ |
Class II |
Ear, Nose, Throat |
| 2024-10-08 |
K240167 |
Single-use Ureteral Access Sheath |
FED |
Class II |
Gastroenterology, Urology |
| 2024-10-04 |
K241434 |
Video Ureteroscope System |
FGB |
— |
— |
| 2024-01-17 |
K231135 |
Video Ureteroscope System |
FGB |
— |
— |
| 2023-06-14 |
K230536 |
Single-use Flexible Rhinolaryngoscope; Digital Video Monitor |
EOB |
Class II |
Ear, Nose, Throat |
| 2023-05-18 |
K230200 |
Single-Use Flexible Ureteroscope |
FGB |
— |
— |
| 2023-05-15 |
K223836 |
Vathin® Video Bronchoscope System |
EOQ |
Class II |
Ear, Nose, Throat |
| 2022-11-18 |
K221581 |
Single-Use Flexible Rhinolaryngoscope |
EOB |
Class II |
Ear, Nose, Throat |
| 2022-11-18 |
K221580 |
Single-Use Flexible Cystoscope |
FAJ |
Class II |
Gastroenterology, Urology |
| 2022-02-28 |
K213635 |
Vathin Video Bronchoscope System |
EOQ |
Class II |
Ear, Nose, Throat |
| 2020-02-13 |
K191828 |
Vathin Video Bronchoscope System |
EOQ |
Class II |
Ear, Nose, Throat |