PillCam Patency System
K-Number: K180171 · 2018-03-08
ApplicantGiven Imaging , Ltd.
Decision Date2018-03-08
Product CodeNSI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
PillCam Patency System is a medical device manufactured by Given Imaging , Ltd.. It received FDA 510(k) clearance on 2018-03-08 under approval number K180171. The device is classified under product code NSI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PillCam Patency System?
PillCam Patency System is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Given Imaging , Ltd.. The 510(k) number is K180171.
When was PillCam Patency System approved by the FDA?
PillCam Patency System received FDA 510(k) clearance on 2018-03-08, under approval number K180171.
What company makes PillCam Patency System?
PillCam Patency System is manufactured by Given Imaging , Ltd..
What is the FDA product code for PillCam Patency System?
The FDA product code for PillCam Patency System is NSI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.