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FDA 510(k)

Zilver 635 Biliary Stent

K-Number: K163018 · 2016-12-23

ApplicantCook Ireland, Ltd.
Decision Date2016-12-23
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

Zilver 635 Biliary Stent is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2016-12-23 under approval number K163018. 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 635 Biliary Stent?

Zilver 635 Biliary Stent is a medical device that received FDA 510(k) clearance on 2016-12-23. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K163018.

When was Zilver 635 Biliary Stent approved by the FDA?

Zilver 635 Biliary Stent received FDA 510(k) clearance on 2016-12-23, under approval number K163018.

What company makes Zilver 635 Biliary Stent?

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

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

The FDA product code for Zilver 635 Biliary Stent is FGE.

Related Clinical Trials

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Other Devices by Cook Ireland, Ltd.

K162717Evolution Esophageal Stent System – Partially Covered K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle K17161914Fr Colon Decompression Set, Macon Colon Decompression Set K171623Nasal Pancreatic Drainage Set K163468Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent

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Related Devices (Code: FGE)

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 K171809Epic Biliary Endoscopic Stent SystemBoston 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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