K221590 is an FDA 510(k) clearance for the NaviCam Small Bowel Capsule Endoscopy System. This device is classified as a System, Imaging, Gastrointestinal, Wireless, Capsule (Class II - Special Controls, product code NEZ).
Submitted by Ankon Technologies Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on December 2, 2022, 183 days after receiving the submission on June 2, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1300.
| 510(k) Number | K221590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2022 |
| Decision Date | December 02, 2022 |
| Days to Decision | 183 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 |