K251658 - Endoflux™ Biliary & Pancreatic Stent Sets

K251658 is an FDA 510(k) clearance for the Endoflux™ Biliary & Pancreatic Stent Sets. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Medi-Globe GmbH (Achenmuehle, DE). The FDA issued a Cleared decision on April 16, 2026 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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