FDA 510(k)

MicroCutter XCHANGE 30 鋸釘器，MicroCutter XCHANGE 30 藍色彈藥筒，MicroCutter XCHANGE 30 白色彈藥筒

K 號：K151081 · 2016-01-15

決定日期2016-01-15

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

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Cardica, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K151081. 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 MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge?

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Cardica, Inc.. The 510(k) number is K151081.

When did MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge receive FDA 510(k) clearance?

MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151081.

Who is the listed applicant for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge?

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

What is the FDA product code for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge?

The FDA product code for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge is GDW.

其他以 Cardica, Inc. 為申請人之記錄

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K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload

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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