# K241934: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether)

- Pathway: 510(k) (Special)
- Applicant: Anx Robotica Corp
- Decided: Jul 31, 2024 after 29 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: 4 generations back to DEN190037 (2020). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231960: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether, Anx Robotica Corporation (2023) Summary page 5.

## Indications for use
The NaviCam Stomach Capsule is intended for visualization of the stomach of patients greater than or equal to 6 years old with BMI less than or equal to 65 and a waist circumference less than or equal to 77 inches. 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/K241934
Methodology: https://510kreport.com/methodology