FDA 510(k)

VersaOne 刀片式套管针 5mm

K号: K152149 · 2016-01-22

决定日期2016-01-22

产品代码GCJ

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决定实质等同

器械摘要

VersaOne Bladed Trocar 5mm is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152149. 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 Bladed Trocar 5mm?

VersaOne Bladed Trocar 5mm is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Covidien. The 510(k) number is K152149.

When did VersaOne Bladed Trocar 5mm receive FDA 510(k) clearance?

VersaOne Bladed Trocar 5mm received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152149.

Who is the listed applicant for VersaOne Bladed Trocar 5mm?

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 Bladed Trocar 5mm?

The FDA product code for VersaOne Bladed Trocar 5mm 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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相关器械（代码：GCJ）

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