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FDA 510(k)

Epic Biliary Endoscopic Stent System

K-Number: K171809 · 2017-08-09

ApplicantBoston Scientific Corporation
Decision Date2017-08-09
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

Epic Biliary Endoscopic Stent System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-08-09 under approval number K171809. 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 Epic Biliary Endoscopic Stent System?

Epic Biliary Endoscopic Stent System is a medical device that received FDA 510(k) clearance on 2017-08-09. It is manufactured by Boston Scientific Corporation. The 510(k) number is K171809.

When was Epic Biliary Endoscopic Stent System approved by the FDA?

Epic Biliary Endoscopic Stent System received FDA 510(k) clearance on 2017-08-09, under approval number K171809.

What company makes Epic Biliary Endoscopic Stent System?

Epic Biliary Endoscopic Stent System is manufactured by Boston Scientific Corporation.

What is the FDA product code for Epic Biliary Endoscopic Stent System?

The FDA product code for Epic Biliary Endoscopic Stent System 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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