# DEN190037: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule

- Pathway: De Novo (Direct)
- Applicant: Anx Robotica, Inc.
- Decided: May 22, 2020 after 283 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K203192: NaviCam Xpress Stomach System (2021), 4 descendants of its own
- 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 (2022), 2 descendants of its own
- 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
- K230694: NaviCam Xpress Stomach System, NaviCam Xpress System (2023), 0 descendants of its own

## Indications for use
The NaviCam Stomach Capsule is intended for visualization of the stomach of adults (≥22 years old) with a BMI less than 38. The system can be used in clinics and hospitals, including ER settings.

Source page: https://510kreport.com/device/DEN190037
Methodology: https://510kreport.com/methodology