FDA 510(k)

YelloPort Elite 端口接入系统

K号: K190592 · 2019-04-29

决定日期2019-04-29

产品代码GCJ

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决定实质等同

器械摘要

YelloPort Elite Port Access System is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Innovations Limited. It received FDA 510(k) clearance on 2019-04-29 under 510(k) number K190592. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the YelloPort Elite Port Access System?

YelloPort Elite Port Access System is a medical device that received FDA 510(k) clearance on 2019-04-29. The listed applicant is Surgical Innovations Limited. The 510(k) number is K190592.

When did YelloPort Elite Port Access System receive FDA 510(k) clearance?

YelloPort Elite Port Access System received FDA 510(k) clearance on 2019-04-29, under 510(k) number K190592.

Who is the listed applicant for YelloPort Elite Port Access System?

The FDA 510(k) record lists Surgical Innovations Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YelloPort Elite Port Access System?

The FDA product code for YelloPort Elite Port Access System is GCJ.

列明Surgical Innovations Limited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。

K210495端口接入系统

相关器械（代码：GCJ）

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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官方来源

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