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FDA 510(k)

WallFlex™ Biliary RX Stent System

K-Number: K223469 · 2023-06-15

ApplicantBoston Scientific Corporation
Decision Date2023-06-15
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

WallFlex™ Biliary RX Stent System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-06-15 under approval number K223469. 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 WallFlex™ Biliary RX Stent System?

WallFlex™ Biliary RX Stent System is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Boston Scientific Corporation. The 510(k) number is K223469.

When was WallFlex™ Biliary RX Stent System approved by the FDA?

WallFlex™ Biliary RX Stent System received FDA 510(k) clearance on 2023-06-15, under approval number K223469.

What company makes WallFlex™ Biliary RX Stent System?

WallFlex™ Biliary RX Stent System is manufactured by Boston Scientific Corporation.

What is the FDA product code for WallFlex™ Biliary RX Stent System?

The FDA product code for WallFlex™ Biliary RX 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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