FDA 510(k)

單次使用可旋轉及可重置式血液夾

K 號：K201771 · 2020-10-19

決定日期2020-10-19

產品代碼PKL

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Anrei Medical (Hangzhou) Co., Ltd. 為申請人之記錄

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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相關器械（代碼：PKL）

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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