| 2025-05-21 |
K250493 |
MotiliCap GI Monitoring System |
NYV |
— |
— |
| 2024-07-31 |
K241934 |
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) |
QKZ |
Class II |
Gastroenterology, Urology |
| 2024-01-05 |
K233229 |
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether |
NEZ |
Class II |
Gastroenterology, Urology |
| 2023-10-03 |
K231960 |
NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether |
QKZ |
Class II |
Gastroenterology, Urology |
| 2023-04-13 |
K230694 |
NaviCam Xpress Stomach System, NaviCam Xpress System |
QKZ |
Class II |
Gastroenterology, Urology |
| 2022-11-22 |
K221608 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether |
QKZ |
Class II |
Gastroenterology, Urology |
| 2021-05-04 |
K203192 |
NaviCam Xpress Stomach System |
QKZ |
Class II |
Gastroenterology, Urology |
| 2020-05-22 |
DEN190037 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule |
QKZ |
Class II |
Gastroenterology, Urology |
| 2020-05-21 |
K201106 |
IntraMarX 3D Radiopaque Marker |
FFX |
Class II |
Gastroenterology, Urology |