FDA 510(k)

X-Suit 近红外胆道金属支架

K号: K150487 · 2016-02-12

决定日期2016-02-12

产品代码FGE

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定Unknown

器械摘要

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.

常见问题

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.

列明Medinol, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：FGE）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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