K251658
- 510(k) number
- K251658
- Device name
- Endoflux Biliary & Pancreatic Stent Sets
- Applicant
- Medi-Globe GmbH DE
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2026-04-16
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K251658.pdf
Official FDA record: K251658
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.