# K053639: Given Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: May 8, 2006 after 129 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: 10 generations back to DEN010002 (2001). 10 ancestors in all.
20 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN010002: Given Diagnostic Imaging System, Given Imaging, Ltd. (2001). Our reading of the summary gave K010312, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN010002, Given Diagnostic Imaging System (Given Imaging, Ltd.), granted Aug 1, 2001; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
- K020341: Given Diagnostic System, Given Imaging, Ltd. (2002) Summary page 1.
- K022362: Given Diagnostics System, Given Imaging, Ltd. (2002) Summary page 1.
- K022980: Modification to Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 1.
- K031033: Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 1.
- K032405: Given Diagnostic System, Given Imaging, Ltd. (2003) Summary page 1.
- K040248: Modification to Given Diagnostic System, Given Imaging, Ltd. (2004) Summary page 1.
- K041149: Given Diagnostic System with M2A Eso Capsule, Given Imaging, Ltd. (2004) Summary page 1.
- K042960: Given Diagnostic System with Pillcam Eso, Given Imaging, Ltd. (2004) Summary page 1.
- K052184: Given Diagnostic System, Given Imaging, Ltd. (2005) Summary page 1.

## Most influential descendants
- K090557: Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System (2009), 19 descendants of its own
- K103025: Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 Capsules (2011), 12 descendants of its own
- K101250: Given Pillcam Platform with Pillcam SB Capsules (2011), 12 descendants of its own
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System (2013), 11 descendants of its own
- K103088: Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R Sensorbelt (2011), 6 descendants of its own

## Indications for use
The Given® AGILE Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures.

Source page: https://510kreport.com/device/K053639
Methodology: https://510kreport.com/methodology