DeviceClearance

Endoflux Biliary & Pancreatic Stent Sets— 510(k) K251658

Substantially Equivalent

Medi-Globe GmbH

FDA 510(k) clearance K251658 for Endoflux Biliary & Pancreatic Stent Sets, Substantially Equivalent on 2026-04-16. Applicant: Medi-Globe GmbH. Device class: 2.

Summary

Medi-Globe GmbH's Endoflux Biliary & Pancreatic Stent Sets are filed under product code FGE (Stents, Drains And Dilators For The Biliary Ducts).

Class II, 21 CFR 876.5010. Gastroenterology and Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).

Medi-Globe filed from Achenmuehle, Germany. The record shows 321 calendar days from receipt to decision (May 30, 2025 to April 16, 2026).

Clearance details

Applicant
Medi-Globe GmbH
Product code
Product code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Achenmuehle, DE
Download summary PDFView on FDA.gov ↗

Recent devices under product code FGE

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.