FDA 510(k)

Surgi Max Ultra

K号: K170107 · 2017-05-03

决定日期2017-05-03

产品代码GEI

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决定实质等同

器械摘要

Surgi Max Ultra is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K170107. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Surgi Max Ultra?

Surgi Max Ultra is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Elliquence, LLC. The 510(k) number is K170107.

When did Surgi Max Ultra receive FDA 510(k) clearance?

Surgi Max Ultra received FDA 510(k) clearance on 2017-05-03, under 510(k) number K170107.

Who is the listed applicant for Surgi Max Ultra?

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

What is the FDA product code for Surgi Max Ultra?

The FDA product code for Surgi Max Ultra is GEI.

列明Elliquence, LLC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：GEI）

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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