FDA 510(k)

一次性聚合物結合夾

K 號：K250643 · 2025-11-20

申請人Hangzhou Kangji Medical Instrument Co., Ltd.

決定日期2025-11-20

產品代碼FZP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Disposable Polymer Ligation Clips is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Kangji Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-11-20 under 510(k) number K250643. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable Polymer Ligation Clips?

Disposable Polymer Ligation Clips is a medical device that received FDA 510(k) clearance on 2025-11-20. The listed applicant is Hangzhou Kangji Medical Instrument Co., Ltd.. The 510(k) number is K250643.

When did Disposable Polymer Ligation Clips receive FDA 510(k) clearance?

Disposable Polymer Ligation Clips received FDA 510(k) clearance on 2025-11-20, under 510(k) number K250643.

Who is the listed applicant for Disposable Polymer Ligation Clips?

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

What is the FDA product code for Disposable Polymer Ligation Clips?

The FDA product code for Disposable Polymer Ligation Clips is FZP.

其他以 Hangzhou Kangji Medical Instrument Co., Ltd. 為申請人之記錄

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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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