FDA 510(k)

Signia Stapler

K号: K160176 · 2016-04-26

决定日期2016-04-26

产品代码GDW

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决定实质等同

器械摘要

Signia Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-04-26 under 510(k) number K160176. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Signia Stapler?

Signia Stapler is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Covidien. The 510(k) number is K160176.

When did Signia Stapler receive FDA 510(k) clearance?

Signia Stapler received FDA 510(k) clearance on 2016-04-26, under 510(k) number K160176.

Who is the listed applicant for Signia Stapler?

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

What is the FDA product code for Signia Stapler?

The FDA product code for Signia Stapler is GDW.

列明Covidien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：GDW）

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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