# K192662: CapsoCam Plus (SV-3) Capsule Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: CapsoVision, Inc.
- Decided: Feb 14, 2020 after 142 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183192 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183192: CapsoCam Plus (SV-3), CapsoVision, Inc. (2019) Summary page 4.

## Most influential descendants
- K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System (2024), 0 descendants of its own

## Recalls of this device
- Feb 26, 2020 · Class II · Z-2536-2020: Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the pati

## 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/K192662
Methodology: https://510kreport.com/methodology