# K090557: Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Sep 28, 2009 after 210 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: 13 generations back to DEN010002 (2001). 14 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070475: Modificaton to: Given Diagnostic Imaging System, Given Imaging, Ltd. (2007) Summary page 1.
- K053639: Given Diagnostic System, Given Imaging, Ltd. (2006) 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
- 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
- K140751: Mirocam Capsule Endoscope System (2014), 5 descendants of its own

## Indications for use
The Given® AGILE Patency System is an accessory to the PiliCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PiliCam video capsule in patients with known or suspected strictures in adults and children from two years of age. The Given PillCam® Platform with the PillCam® SB Capsules is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from two years of age. 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/K090557
Methodology: https://510kreport.com/methodology