FDA 510(k)

達及 CQ'ENCE 環形釘針

K 號：K192566 · 2019-10-17

決定日期2019-10-17

產品代碼GDW

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

Reach and CQ'ENCE Circular Staplers is the device name listed in this FDA 510(k) record. The listed applicant is Reach Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-17 under 510(k) number K192566. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reach and CQ'ENCE Circular Staplers?

Reach and CQ'ENCE Circular Staplers is a medical device that received FDA 510(k) clearance on 2019-10-17. The listed applicant is Reach Surgical, Inc.. The 510(k) number is K192566.

When did Reach and CQ'ENCE Circular Staplers receive FDA 510(k) clearance?

Reach and CQ'ENCE Circular Staplers received FDA 510(k) clearance on 2019-10-17, under 510(k) number K192566.

Who is the listed applicant for Reach and CQ'ENCE Circular Staplers?

The FDA 510(k) record lists Reach Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reach and CQ'ENCE Circular Staplers?

The FDA product code for Reach and CQ'ENCE Circular Staplers is GDW.

相關器械（代碼：GDW）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：GDW）

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