The following data is part of a premarket notification filed by Anx Robotica Corp with the FDA for 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.
| Device ID | K221608 |
| 510k Number | K221608 |
| Device Name: | 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 |
| Classification | Magnetically Maneuvered Capsule Endoscopy System |
| Applicant | AnX Robotica Corp 6010 W. Spring Creek Parkway Plano, TX 75024 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas AnX Robotica Corp 6010 W. Spring Creek Parkway Plano, TX 75024 |
| Product Code | QKZ |
| CFR Regulation Number | 876.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-03 |
| Decision Date | 2022-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015518287 | K221608 | 000 |