FDA 510(k)

Endoflux Biliary & Pancreatic Stent Sets

K-Number: K251658 · 2026-04-16

Decision Date2026-04-16

Product CodeFGE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Endoflux Biliary & Pancreatic Stent Sets is a medical device manufactured by Medi-Globe GmbH. It received FDA 510(k) clearance on 2026-04-16 under approval number K251658. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Medi-Globe GmbH. The 510(k) number is K251658.

When was Endoflux Biliary & Pancreatic Stent Sets approved by the FDA?

Endoflux Biliary & Pancreatic Stent Sets received FDA 510(k) clearance on 2026-04-16, under approval number K251658.

What company makes Endoflux Biliary & Pancreatic Stent Sets?

Endoflux Biliary & Pancreatic Stent Sets is manufactured by Medi-Globe GmbH.

What is the FDA product code for Endoflux Biliary & Pancreatic Stent Sets?

The FDA product code for Endoflux Biliary & Pancreatic Stent Sets is FGE.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.