QKZ
6 FDA 510(k) clearances · Product code
172 daysmedian time to decision
283 days90th percentile
6clearances measured
FDA profile
- Official device name
- Magnetically Maneuvered Capsule Endoscopy System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1310
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
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| 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 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 |
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Every clearance here is in the API, with alerts when new ones post.