510(k) K221608
- Device
- 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
- Applicant
- AnX Robotica Corp
- 510(k) number
- K221608
- Product code
- QKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-22
- Date received
- 2022-06-03
- 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 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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