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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 the device name listed in this FDA 510(k) record. The listed applicant is Medinol, Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) 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. The listed applicant is Medinol, Ltd.. The 510(k) number is K150487.

When did X-Suit NIR Biliary Metallic Stent receive FDA 510(k) clearance?

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

Who is the listed applicant for X-Suit NIR Biliary Metallic Stent?

The FDA 510(k) record lists Medinol, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Medinol, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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