# K233229: NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether

- Pathway: 510(k) (Traditional)
- Applicant: Anx Robotica Corporation
- Decided: Jan 5, 2024 after 99 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Given PillCam Platform with PillCam SB Capsules: named in the summary without a submission number
- (no number) Given AGILE Patency System: named in the summary without a submission number

## Indications for use
The NaviCam Small Bowel (SB) Capsule Endoscopy System is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 2 years of age. The NaviCam Tether is an accessory of the NaviCam SB Capsule. It is intended to aid the capsule for visualizing the esophagus prior to the capsule's release into the gastrointestinal tract for a SB capsule endoscopy procedure in adults (≥ 22 years).

Source page: https://510kreport.com/device/K233229
Methodology: https://510kreport.com/methodology