FDA 510(k)

Wilson-Cook Achalasia Balloon

K-Number: K182895 · 2019-01-25

Decision Date2019-01-25

Product CodePID

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Wilson-Cook Achalasia Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-01-25 under 510(k) 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. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K182895.

When did Wilson-Cook Achalasia Balloon receive FDA 510(k) clearance?

Wilson-Cook Achalasia Balloon received FDA 510(k) clearance on 2019-01-25, under 510(k) number K182895.

Who is the listed applicant for Wilson-Cook Achalasia Balloon?

The FDA 510(k) record lists Wilson-Cook Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.