FDA Product Code
FDA Product Code QKZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1310
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K241934 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) | Anx Robotica Corp | 2024-07-31 | Special | PDF ↗ |
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corporation | 2023-10-03 | Traditional | PDF ↗ |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp | 2023-04-13 | Special | PDF ↗ |
| 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 | Anx Robotica Corp | 2022-11-22 | Traditional | PDF ↗ |
| K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | 2021-05-04 | Traditional | PDF ↗ |
| DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020-05-22 | Direct | — |
Product code QKZ · Class II · Gastroenterology, Urology. Data: openFDA.