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FDA 510(k)

止血夾

K 號:K241005 · 2025-01-02

決定日期2025-01-02
產品代碼PKL
諮詢委員會GU
決定相當於

器材摘要

Haemostasis Clips is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K241005. 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 Haemostasis Clips?

Haemostasis Clips is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. The 510(k) number is K241005.

When did Haemostasis Clips receive FDA 510(k) clearance?

Haemostasis Clips received FDA 510(k) clearance on 2025-01-02, under 510(k) number K241005.

Who is the listed applicant for Haemostasis Clips?

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

What is the FDA product code for Haemostasis Clips?

The FDA product code for Haemostasis Clips is PKL.

相關臨床試驗

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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。

官方來源

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