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FDA 510(k)

X-Suit NIR Biliary Metallic Stent

K-Number: K150487 · 2016-02-12

ApplicantMedinol, Ltd.
Decision Date2016-02-12
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

X-Suit NIR Biliary Metallic Stent is a medical device manufactured by Medinol, Ltd.. It received FDA 510(k) clearance on 2016-02-12 under approval number K150487. 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 X-Suit NIR Biliary Metallic Stent?

X-Suit NIR Biliary Metallic Stent is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Medinol, Ltd.. The 510(k) number is K150487.

When was X-Suit NIR Biliary Metallic Stent approved by the FDA?

X-Suit NIR Biliary Metallic Stent received FDA 510(k) clearance on 2016-02-12, under approval number K150487.

What company makes X-Suit NIR Biliary Metallic Stent?

X-Suit NIR Biliary Metallic Stent is manufactured by Medinol, Ltd..

What is the FDA product code for X-Suit NIR Biliary Metallic Stent?

The FDA product code for X-Suit NIR Biliary Metallic 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. 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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