# K140284: Given Pillcam Ugi Capsule Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Dec 17, 2014 after 316 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: 16 generations back to DEN010002 (2001). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071153: Given Diagnostic System with Pillcam ESO2 Capsule, Given Imaging, Ltd. (2007) Summary page 4.
- K103025: Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules, Given Imaging, Ltd. (2011) Summary page 4.
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System, Given Imaging, Ltd. (2013) Summary page 4.
- DEN120023: Given Pillcam Colon 2 Capsule Endoscopy System, Given Imaging, Ltd. (2014). Our reading of the summary gave K123666, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120023, Given Pillcam Colon 2 Capsule Endoscopy System (Given Imaging, Ltd.), granted Jan 29, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Indications for use
The PillCam UGI capsule endoscopy system is intended for visualization of the upper gastrointestinal tract (esophagus, stomach, duodenum). It may be used for visualization of blood in the upper gastrointestinal tract (esophagus, stomach, duodenum) in patients who are hemodynamically stable and at least18 years of age.

Source page: https://510kreport.com/device/K140284
Methodology: https://510kreport.com/methodology