# K180171: PillCam Patency System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Mar 8, 2018 after 45 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: 14 generations back to DEN010002 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090557: Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System, Given Imaging, Ltd. (2009) Summary page 5.

## Indications for use
The PillCam 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. The PillCam Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system. Therefore, the PillCam Patency System is intended to be used: • prior to PillCam SB capsule in adults and children from 2 years of age, or • prior to PillCam UGI, COLON, and Crohn’s capsules in adults

Source page: https://510kreport.com/device/K180171
Methodology: https://510kreport.com/methodology