FDA 510(k)

HandX™ 雙極剪

K 號：K230491 · 2023-05-10

決定日期2023-05-10

產品代碼GCJ

諮詢委員會GU

決定相當於

器材摘要

HandX™ Monopolar Scissors 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 2023-05-10 under 510(k) number K230491. 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 HandX™ Monopolar Scissors?

HandX™ Monopolar Scissors is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is Human Xtensions , Ltd.. The 510(k) number is K230491.

When did HandX™ Monopolar Scissors receive FDA 510(k) clearance?

HandX™ Monopolar Scissors received FDA 510(k) clearance on 2023-05-10, under 510(k) number K230491.

Who is the listed applicant for HandX™ Monopolar Scissors?

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 HandX™ Monopolar Scissors?

The FDA product code for HandX™ Monopolar Scissors 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）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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