K251291
- 510(k) number
- K251291
- Device name
- Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- Applicant
- Boston Scientific MA · US
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2025-07-03
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251291.pdf
Official FDA record: K251291
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.