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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 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.

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. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Medi-Globe GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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