# K161773: CapsoCam Plus (SV-3) Capsule Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: CapsoVision, Inc.
- Decided: Oct 21, 2016 after 115 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
Longest line of descent: 14 generations back to DEN010002 (2001). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151635: CapsoCam (SV-1), CapsoVision, Inc. (2016) Summary page 4.

## Indications for use
The CapsoCam® Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

Source page: https://510kreport.com/device/K161773
Methodology: https://510kreport.com/methodology