FDA 510(k)

SpeediCath Flex Coude

K号: K161672 · 2016-09-29

决定日期2016-09-29

产品代码GBM

咨询委员会GU

决定Substantially Equivalent

器械摘要

SpeediCath Flex Coude is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K161672. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SpeediCath Flex Coude?

SpeediCath Flex Coude is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Coloplast Corp.. The 510(k) number is K161672.

When did SpeediCath Flex Coude receive FDA 510(k) clearance?

SpeediCath Flex Coude received FDA 510(k) clearance on 2016-09-29, under 510(k) number K161672.

Who is the listed applicant for SpeediCath Flex Coude?

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

What is the FDA product code for SpeediCath Flex Coude?

The FDA product code for SpeediCath Flex Coude is GBM.

列明Coloplast Corp.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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