FDA 510(k)

一次性聚合物结扎夹

K号: K250643 · 2025-11-20

申请人Hangzhou Kangji Medical Instrument Co., Ltd.

决定日期2025-11-20

产品代码FZP

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决定实质等同

器械摘要

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.

常见问题

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.

列明Hangzhou Kangji Medical Instrument Co., Ltd.为申报人的其他记录

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K233263一次性套管 K232401一次性Veress针

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