FDA 510(k)

內視鏡線性切釘器及單次使用裝填單位

K 號：K181620 · 2018-09-18

決定日期2018-09-18

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

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-09-18 under 510(k) number K181620. 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 Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K181620.

When did Endoscopic Linear Cutting Staplers and Loading Units for Single Use receive FDA 510(k) clearance?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181620.

Who is the listed applicant for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

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

What is the FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

The FDA product code for Endoscopic Linear Cutting Staplers and Loading Units for Single Use is GDW.

其他以 Ezisurg (Suzhou) Medical 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。

K182217單次使用線性切釘器及裝填單位，單次使用圓形釘釘器

相關器械（代碼：GDW）

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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