# K071153: Given Diagnostic System with Pillcam ESO2 Capsule

- Pathway: 510(k) (Special)
- Applicant: Given Imaging, Ltd.
- Decided: Jun 11, 2007 after 47 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: 9 generations back to DEN010002 (2001). 9 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 23 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.
- K042960: Given Diagnostic System with Pillcam Eso, Given Imaging, Ltd. (2004) Summary page 1.

## Most influential descendants
- K103025: Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 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
- K170210: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (2017), 4 descendants of its own
- K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2021), 3 descendants of its own
- K170438: MiroCam Capsule Endoscope System (2018), 2 descendants of its own

## Indications for use
The Given® Diagnostic System with the PillCamTM ESO2 Capsule is intended for visualization of the esophageal mucosa

Source page: https://510kreport.com/device/K071153
Methodology: https://510kreport.com/methodology