FDA 510(k)

ShineMed 重裝式開放式剪釘器，ShineMed 弯曲式內腔剪釘器

K 號：K160969 · 2016-12-12

決定日期2016-12-12

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

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is the device name listed in this FDA 510(k) record. The listed applicant is Shinemed, LLC. It received FDA 510(k) clearance on 2016-12-12 under 510(k) number K160969. 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 ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler is a medical device that received FDA 510(k) clearance on 2016-12-12. The listed applicant is Shinemed, LLC. The 510(k) number is K160969.

When did ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler receive FDA 510(k) clearance?

ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler received FDA 510(k) clearance on 2016-12-12, under 510(k) number K160969.

Who is the listed applicant for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

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

What is the FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler?

The FDA product code for ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler 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）

官方來源