FDA 510(k)

EndoGI 胆道支架系統

K 號：K193600 · 2020-06-26

決定日期2020-06-26

產品代碼FGE

諮詢委員會GU

決定相當於

器材摘要

EndoGI Biliary Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Endogi Medical, Ltd.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K193600. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoGI Biliary Stent System?

EndoGI Biliary Stent System is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Endogi Medical, Ltd.. The 510(k) number is K193600.

When did EndoGI Biliary Stent System receive FDA 510(k) clearance?

EndoGI Biliary Stent System received FDA 510(k) clearance on 2020-06-26, under 510(k) number K193600.

Who is the listed applicant for EndoGI Biliary Stent System?

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

What is the FDA product code for EndoGI Biliary Stent System?

The FDA product code for EndoGI Biliary Stent System is FGE.

其他以 Endogi Medical, Ltd. 為申請人之記錄

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K232596EndoGI S-Path 胆道支架系統

相關器械（代碼：FGE）

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。

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