Wilson-Cook Achalasia Balloon
K-Number: K182895 · 2019-01-25
ApplicantWilson-Cook Medical, Inc.
Decision Date2019-01-25
Product CodePID
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Wilson-Cook Achalasia Balloon is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-01-25 under approval number K182895. The device is classified under product code PID. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wilson-Cook Achalasia Balloon?
Wilson-Cook Achalasia Balloon is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K182895.
When was Wilson-Cook Achalasia Balloon approved by the FDA?
Wilson-Cook Achalasia Balloon received FDA 510(k) clearance on 2019-01-25, under approval number K182895.
What company makes Wilson-Cook Achalasia Balloon?
Wilson-Cook Achalasia Balloon is manufactured by Wilson-Cook Medical, Inc..
What is the FDA product code for Wilson-Cook Achalasia Balloon?
The FDA product code for Wilson-Cook Achalasia Balloon is PID.
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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.