The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before releasing the NaviCam SB capsule into the stomach for a routing…
The NaviCam Capsule/Tether is a NaviCam SB capsule attached to a Tether to allow the physician to view the esophagus before releasing the NaviCam SB capsule into the stomach for a routing examination of the small bowel.
Who Else Makes It
Registered in Hubei. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for NaviCam SB Capsule/Tether | Listed by | ANX Robotica Corp., United States |
| FDA product code | NEZ |
| Device type | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2026-02-09 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.