FDA 510(k)

单极钩

K号: K203603 · 2021-02-01

决定日期2021-02-01

产品代码GCJ

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决定实质等同

器械摘要

Monopolar Hook is the device name listed in this FDA 510(k) record. The listed applicant is Human Xtensions , Ltd.. It received FDA 510(k) clearance on 2021-02-01 under 510(k) number K203603. 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 Monopolar Hook?

Monopolar Hook is a medical device that received FDA 510(k) clearance on 2021-02-01. The listed applicant is Human Xtensions , Ltd.. The 510(k) number is K203603.

When did Monopolar Hook receive FDA 510(k) clearance?

Monopolar Hook received FDA 510(k) clearance on 2021-02-01, under 510(k) number K203603.

Who is the listed applicant for Monopolar Hook?

The FDA 510(k) record lists Human Xtensions , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monopolar Hook?

The FDA product code for Monopolar Hook is GCJ.

列明Human Xtensions , 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：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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