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
FDA 510(k) clearance K221608 · decided 2022-11-22
Clearance details
- K-number
- K221608
- Device name
- 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
- Decision
- Substantially Equivalent
- Date received
- 2022-06-03
- Decision date
- 2022-11-22
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- QKZ
- Device class
- 2
- Regulation number
- 876.1310
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plano, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) (K241934) | Anx Robotica Corp | 2024-07-31 |
| NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether (K231960) | Anx Robotica Corporation | 2023-10-03 |
| NaviCam Xpress Stomach System, NaviCam Xpress System (K230694) | Anx Robotica Corp | 2023-04-13 |
| NaviCam Xpress Stomach System (K203192) | Anx Robotica Corp | 2021-05-04 |
| NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (DEN190037) | Anx Robotica, Inc. | 2020-05-22 |
Recalls involving this device
No recalls on record reference this clearance.