Endoflux™ 胆胰支架組
K 號：K251658 · 2026-04-16
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器材摘要
Endoflux™ Biliary & Pancreatic Stent Sets is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Globe GmbH. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K251658. 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 Endoflux™ Biliary & Pancreatic Stent Sets?
Endoflux™ Biliary & Pancreatic Stent Sets is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Medi-Globe GmbH. The 510(k) number is K251658.
When did Endoflux™ Biliary & Pancreatic Stent Sets receive FDA 510(k) clearance?
Endoflux™ Biliary & Pancreatic Stent Sets received FDA 510(k) clearance on 2026-04-16, under 510(k) number K251658.
Who is the listed applicant for Endoflux™ Biliary & Pancreatic Stent Sets?
The FDA 510(k) record lists Medi-Globe GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Endoflux™ Biliary & Pancreatic Stent Sets?
The FDA product code for Endoflux™ Biliary & Pancreatic Stent Sets is FGE.
相關臨床試驗
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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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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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