FDA 510(k)

VersaOne Bladeless Trocar

K号: K162584 · 2016-10-18

决定日期2016-10-18

产品代码GCJ

咨询委员会GU

决定Substantially Equivalent

器械摘要

VersaOne Bladeless Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162584. 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 VersaOne Bladeless Trocar?

VersaOne Bladeless Trocar is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Covidien. The 510(k) number is K162584.

When did VersaOne Bladeless Trocar receive FDA 510(k) clearance?

VersaOne Bladeless Trocar received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162584.

Who is the listed applicant for VersaOne Bladeless Trocar?

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 VersaOne Bladeless Trocar?

The FDA product code for VersaOne Bladeless Trocar is GCJ.

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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