K250409
- 510(k) number
- K250409
- Device name
- Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Decision date
- 2025-10-21
- Date received
- 2025-02-13
- 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: K250409.pdf
Official FDA record: K250409
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.