# K022980: Modification to Given Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Feb 27, 2003 after 171 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: 3 generations back to DEN010002 (2001). 3 ancestors in all.
37 later devices descend from it; 10 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.

## Most influential descendants
- K031033: Given Diagnostic System (2003), 36 descendants of its own
- K032405: Given Diagnostic System (2003), 35 descendants of its own
- K040248: Modification to Given Diagnostic System (2004), 34 descendants of its own
- K041149: Given Diagnostic System with M2A Eso Capsule (2004), 33 descendants of its own
- K042960: Given Diagnostic System with Pillcam Eso (2004), 32 descendants of its own

## Indications for use
The Given@ Diagnostic System is intended for visualization of the small bowel mucosa. It may be used as an adjunctive tool in the detection of abnormalities of the small bowel. The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas

Source page: https://510kreport.com/device/K022980
Methodology: https://510kreport.com/methodology