# K221608: 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

- Pathway: 510(k) (Traditional)
- Applicant: Anx Robotica Corp
- Decided: Nov 22, 2022 after 172 days
- Product code: QKZ (Magnetically Maneuvered Capsule Endoscopy System)
- Device class: 2
- Regulation: 21 CFR 876.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN190037 (2020). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN190037: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule, Anx Robotica, Inc. (2020) Summary page 4.
- K203192: NaviCam Xpress Stomach System, Anx Robotica Corp (2021) Summary page 4.

## Most influential descendants
- K231960: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether (2023), 1 descendant of its own
- K241934: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) (2024), 0 descendants of its own

## Indications for use
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (>/=22 years) with BMI < 38. The system can be used in clinics and hospitals, including ER settings. The NaviCam Tether is an accessory of the NaviCam Stomach Capsule. It is intended to aid the Capsule for visualizing the esophagus (not magnetically maneuvered) prior to the Capsule’s release into the stomach for a stomach capsule endoscopy (MCCE) procedure.

Source page: https://510kreport.com/device/K221608
Methodology: https://510kreport.com/methodology