K233229 is an FDA 510(k) clearance for the NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether. This device is classified as a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II - Special Controls, product code NEZ).
Submitted by Anx Robotica Corporation (Plano, US). The FDA issued a Cleared decision on January 5, 2024, 99 days after receiving the submission on September 28, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K233229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2023 |
| Decision Date | January 05, 2024 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NEZ - System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1300 |