The following data is part of a De Novo classification by Anx Robotica, Inc. with the FDA for Navicam Capsule Endoscope System With Navicam Stomach Capsule.
| DeNovo ID | DEN190037 |
| Device Name: | NaviCam Capsule Endoscope System With NaviCam Stomach Capsule |
| Classification | Magnetically Maneuvered Capsule Endoscopy System |
| Applicant | AnX Robotica, Inc. 8 The Green, Ste A Dover, DE 19901 |
| Contact | David Duan |
| Product Code | QKZ |
| CFR Regulation Number | 876.1310 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2019-08-13 |
| Decision Date | 2020-05-22 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015518201 | DEN190037 | 000 |
| 00850015518195 | DEN190037 | 000 |
| 00850015518188 | DEN190037 | 000 |
| 00850015518072 | DEN190037 | 000 |