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FDA 510(k)

Tri-Ex Extraction Balloon with Multiple Sizing

K-Number: K193344 · 2019-12-13

ApplicantWilson-Cook Medical, Inc.
Decision Date2019-12-13
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tri-Ex Extraction Balloon with Multiple Sizing is a medical device manufactured by Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-12-13 under approval number K193344. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tri-Ex Extraction Balloon with Multiple Sizing?

Tri-Ex Extraction Balloon with Multiple Sizing is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Wilson-Cook Medical, Inc.. The 510(k) number is K193344.

When was Tri-Ex Extraction Balloon with Multiple Sizing approved by the FDA?

Tri-Ex Extraction Balloon with Multiple Sizing received FDA 510(k) clearance on 2019-12-13, under approval number K193344.

What company makes Tri-Ex Extraction Balloon with Multiple Sizing?

Tri-Ex Extraction Balloon with Multiple Sizing is manufactured by Wilson-Cook Medical, Inc..

What is the FDA product code for Tri-Ex Extraction Balloon with Multiple Sizing?

The FDA product code for Tri-Ex Extraction Balloon with Multiple Sizing is GCA.

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Related Devices (Code: GCA)

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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.

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