FDA 510(k)

单次使用可旋转和可重新定位的血液夹

K号: K201771 · 2020-10-19

决定日期2020-10-19

产品代码PKL

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决定实质等同

器械摘要

Single Use Rotatable and Repositionable Hemoclip is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-10-19 under 510(k) number K201771. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Single Use Rotatable and Repositionable Hemoclip?

Single Use Rotatable and Repositionable Hemoclip is a medical device that received FDA 510(k) clearance on 2020-10-19. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K201771.

When did Single Use Rotatable and Repositionable Hemoclip receive FDA 510(k) clearance?

Single Use Rotatable and Repositionable Hemoclip received FDA 510(k) clearance on 2020-10-19, under 510(k) number K201771.

Who is the listed applicant for Single Use Rotatable and Repositionable Hemoclip?

The FDA 510(k) record lists Anrei Medical (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Rotatable and Repositionable Hemoclip?

The FDA product code for Single Use Rotatable and Repositionable Hemoclip is PKL.

列明Anrei Medical (Hangzhou) Co., Ltd.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：PKL）

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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