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FDA 510(k)

Tri-Ex Extraction Balloon With Multiple Sizing

K-Number: K170292 · 2017-09-20

ApplicantWilson-Cook Medical, Inc.
Decision Date2017-09-20
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tri-Ex Extraction Balloon With Multiple Sizing 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 2017-09-20 under 510(k) number K170292. 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 2017-09-20. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K170292.

When did Tri-Ex Extraction Balloon With Multiple Sizing receive FDA 510(k) clearance?

Tri-Ex Extraction Balloon With Multiple Sizing received FDA 510(k) clearance on 2017-09-20, under 510(k) number K170292.

Who is the listed applicant for Tri-Ex Extraction Balloon With Multiple Sizing?

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 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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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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