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FDA 510(k)

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

K-Number: K182980 · 2018-11-16

ApplicantCook Ireland, Ltd.
Decision Date2018-11-16
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2018-11-16 under approval number K182980. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Zilver 518 Biliary Stent, Zilver 635 Biliary Stent?

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent is a medical device that received FDA 510(k) clearance on 2018-11-16. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K182980.

When was Zilver 518 Biliary Stent, Zilver 635 Biliary Stent approved by the FDA?

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent received FDA 510(k) clearance on 2018-11-16, under approval number K182980.

What company makes Zilver 518 Biliary Stent, Zilver 635 Biliary Stent?

Zilver 518 Biliary Stent, Zilver 635 Biliary Stent is manufactured by Cook Ireland, Ltd..

What is the FDA product code for Zilver 518 Biliary Stent, Zilver 635 Biliary Stent?

The FDA product code for Zilver 518 Biliary Stent, Zilver 635 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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