NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
FDA 510(k) clearance K241934 · decided 2024-07-31
Clearance details
- K-number
- K241934
- Device name
- NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)
- Applicant
- Anx Robotica Corp
- Decision
- Substantially Equivalent
- Date received
- 2024-07-02
- Decision date
- 2024-07-31
- Days to decision
- 29 days
- Clearance type
- Special
- 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 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 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 (K221608) | Anx Robotica Corp | 2022-11-22 |
| 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.