FDA 510(k)

單極針

K 號：K203603 · 2021-02-01

決定日期2021-02-01

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Human Xtensions , Ltd. 為申請人之記錄

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相關器械（代碼：GCJ）

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官方來源

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