FDA 510(k)

EndoGI S-Path 胆道支架系統

K 號：K232596 · 2023-09-27

決定日期2023-09-27

產品代碼FGE

諮詢委員會GU

決定Unknown

器材摘要

EndoGI S-Path 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 2023-09-27 under 510(k) number K232596. 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 EndoGI S-Path Biliary Stent System?

EndoGI S-Path Biliary Stent System is a medical device that received FDA 510(k) clearance on 2023-09-27. The listed applicant is Endogi Medical, Ltd.. The 510(k) number is K232596.

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

EndoGI S-Path Biliary Stent System received FDA 510(k) clearance on 2023-09-27, under 510(k) number K232596.

Who is the listed applicant for EndoGI S-Path 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 S-Path Biliary Stent System?

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

其他以 Endogi Medical, Ltd. 為申請人之記錄

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K193600EndoGI 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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