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FDA 510(k)

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter

K-Number: K171548 · 2017-10-13

Decision Date2017-10-13
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter 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 2017-10-13 under 510(k) number K171548. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter?

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K171548.

When did Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter receive FDA 510(k) clearance?

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171548.

Who is the listed applicant for Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter?

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 Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter?

The FDA product code for Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter is FGE.

Other records listing Wilson-Cook Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 34 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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