# K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: CapsoVision, Inc.
- Decided: Dec 4, 2024 after 92 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: 18 generations back to DEN010002 (2001). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192662: CapsoCam Plus (SV-3) Capsule Endoscopy System, CapsoVision, Inc. (2020) Summary page 5.
- K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E, Given Imaging Ltd. (Medtronic) (2021) Summary page 5.

## Indications for use
The CapsoCam Plus SV-3 capsule endoscopy system is intended for visualization of the small bowel mucosa in adults and children older than two years of age. It may be used as a tool in the detection of abnormalities of the small bowel.

Source page: https://510kreport.com/device/K242643
Methodology: https://510kreport.com/methodology