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FDA 510(k)

GORE VIABIL 短續肝內支架

K 號:K170740 · 2017-05-08

決定日期2017-05-08
產品代碼FGE
諮詢委員會GU
決定Unknown

器材摘要

GORE VIABIL Short Wire Biliary Endoprosthesis is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170740. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the GORE VIABIL Short Wire Biliary Endoprosthesis?

GORE VIABIL Short Wire Biliary Endoprosthesis is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K170740.

When did GORE VIABIL Short Wire Biliary Endoprosthesis receive FDA 510(k) clearance?

GORE VIABIL Short Wire Biliary Endoprosthesis received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170740.

Who is the listed applicant for GORE VIABIL Short Wire Biliary Endoprosthesis?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE VIABIL Short Wire Biliary Endoprosthesis?

The FDA product code for GORE VIABIL Short Wire Biliary Endoprosthesis is FGE.

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其他以 W. L. Gore & Associates, Inc. 為申請人之記錄

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相關器械(代碼:FGE)

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官方來源

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