510(k) DEN190037
- Device
- NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
- Applicant
- Anx Robotica, Inc.
- 510(k) number
- DEN190037
- Product code
- QKZ
- Decision
- Unknown (DENG)
- Decision date
- 2020-05-22
- Date received
- 2019-08-13
- Regulation
- 876.1310
- Classification name
- Magnetically Maneuvered Capsule Endoscopy System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- David Duan
- Address
- 8 The Green, Suite A Dover DE US 19901 19901
FDA Registration Numbers#
- 3016544248
- 3015198783
- 3017400296
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QKZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K231960 | NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether | Anx Robotica Corporation | 2023-10-03 |
| K230694 | NaviCam Xpress Stomach System, NaviCam Xpress System | Anx Robotica Corp | 2023-04-13 |
| 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 |
| K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | 2021-05-04 |