# K041149: Given Diagnostic System with M2A Eso Capsule

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Oct 25, 2004 after 175 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: 7 generations back to DEN010002 (2001). 7 ancestors in all.
33 later devices descend from it; 5 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)
- 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.

## Most influential descendants
- K042960: Given Diagnostic System with Pillcam Eso (2004), 32 descendants of its own
- 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

## Indications for use
The Given® Diagnostic System with the PillCamTM ESO Capsule is intended for the visualization of the esophagus.

Source page: https://510kreport.com/device/K041149
Methodology: https://510kreport.com/methodology