510(k) K231960
- Device
- NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether
- Applicant
- Anx Robotica Corporation
- 510(k) number
- K231960
- Product code
- QKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-03
- Date received
- 2023-07-03
- Regulation
- 876.1310
- Classification name
- Magnetically Maneuvered Capsule Endoscopy System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Tim Thomas
- Address
- 6010 W Spring Creek Pkwy. Plano TX US 75024 75024
FDA Registration Numbers#
- 3016544248
- 3015198783
- 3017400296
Source Documents#
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 |
| 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 |
| DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | 2020-05-22 |