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FDA 510(k)

Compass BDS Biliary Stent

K-Number: K213946 · 2022-05-09

ApplicantCook Ireland, Ltd.
Decision Date2022-05-09
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Compass BDS Biliary Stent is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2022-05-09 under approval number K213946. 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 Compass BDS Biliary Stent?

Compass BDS Biliary Stent is a medical device that received FDA 510(k) clearance on 2022-05-09. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K213946.

When was Compass BDS Biliary Stent approved by the FDA?

Compass BDS Biliary Stent received FDA 510(k) clearance on 2022-05-09, under approval number K213946.

What company makes Compass BDS Biliary Stent?

Compass BDS Biliary Stent is manufactured by Cook Ireland, Ltd..

What is the FDA product code for Compass BDS Biliary Stent?

The FDA product code for Compass BDS Biliary Stent is FGE.

Related Clinical Trials

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Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

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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