FDA 510(k)

VersaOne 光学套管带固定气球导管，VersaOne 通用固定气球导管

K号: K213818 · 2022-06-27

决定日期2022-06-27

产品代码GCJ

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决定实质等同

器械摘要

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K213818. 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 Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula?

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is Covidien. The 510(k) number is K213818.

When did VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula receive FDA 510(k) clearance?

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula received FDA 510(k) clearance on 2022-06-27, under 510(k) number K213818.

Who is the listed applicant for VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula?

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 Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula?

The FDA product code for VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula 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）

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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