# K042960: Given Diagnostic System with Pillcam Eso

- Pathway: 510(k) (Special)
- Applicant: Given Imaging, Ltd.
- Decided: Nov 24, 2004 after 28 days
- Product code: NSI (System, Imaging, Esophageal, 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: 8 generations back to DEN010002 (2001). 8 ancestors in all.
32 later devices descend from it; 4 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041149: Given Diagnostic System with M2A Eso Capsule, Given Imaging, Ltd. (2004) Summary page 1.

## Most influential descendants
- K052184: Given Diagnostic System (2005), 30 descendants of its own
- K060805: Modification to Given Diagnostic System (2006), 28 descendants of its own
- K062786: Modification to Given Diagnostic System (2006), 26 descendants of its own
- K070475: Modificaton to: Given Diagnostic Imaging System (2007), 25 descendants of its own
- K053639: Given Diagnostic System (2006), 20 descendants of its own

## Indications for use
The Given® Diagnostic System with the PillCam™ ESO Capsule is intended for the visualization of esophageal mucosa.

Source page: https://510kreport.com/device/K042960
Methodology: https://510kreport.com/methodology