NaviCam Tether
The NaviCam Tether holds and controls a NaviCam stomach capsule while it images the oesophagus before release into the stomach. It is a sterile, disposable accessory used with the NaviCam…
The NaviCam Tether holds and controls a NaviCam stomach capsule while it images the oesophagus before release into the stomach. It is a sterile, disposable accessory used with the NaviCam capsule endoscopy systems in clinics or hospitals, including emergency departments.
A capsule cradle connects to tubing and a syringe connector. The cradle retains the capsule, and the tubing controls its downward movement in the oesophagus. After the examination, air from a connected syringe releases the capsule so that stomach imaging can continue.
Listed Item
Tether Accessory. The NaviCam Capsule and NaviCam Tether are disposable sterile products, which serve as an accessory to the NaviCam System to allow for examination of the esophagus prior to releasing the NaviCam Capsule into the stomach. The NaviCam Tether is comprised of a tube which on one end is attached to a capsule cradle and on the other end is attached to a syringe connector. The capsule cradle holds the capsule in place while examining the esophagus. The tube is used to control the downward speed of the capsule in the esophagus. The syringe connector serves for releasing the capsule by attaching to it a standard syringe filled with air. 2 NaviCam Stomach Capsule and NaviCam Tether. After the examination of the esophagus is accomplished, the syringe piston is pushed to release the capsule for examining the stomach with the NaviCam System.
Capsule Use
Oesophageal imaging with the tether is not magnetically manoeuvred. The compatible stomach capsule procedure is intended for adults aged at least 22 years with a body mass index below 38.
Who Else Makes It
Concentrated in Hubei (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ankon Technologies Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 2 |
| Ankon Medical Technologies (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 2 |
Record
| Listed by | ANX Robotica Corp., United States |
|---|---|
| FDA product code | QKZ |
| Device type | Magnetically Maneuvered Capsule Endoscopy System |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1310 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K221608 |
| Record published | 2023-01-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CEE-1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NaviCam Capsule Endoscope System | ANX Robotica Corp. | 3 |
| NaviCam Stomach System | ANX Robotica Corp. | 1 |
| NaviCam Xpress Stomach Capsule Endoscope System, NaviCam Xpress Stomach System | ANX Robotica Corp. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241934 | 2024-07-31 |
| K231960 | 2023-10-03 |
| K230694 | 2023-04-13 |
| K221608 | 2022-11-22 |
| K203192 | 2021-05-04 |
| DEN190037 | 2020-05-22 |
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.