K250910
- 510(k) number
- K250910
- Device name
- Optilume® High Pressure Urological Balloon Dilation Catheter
- Applicant
- Urotronic, Inc. MN · US
- Product code
- EZN — Dilator, Catheter, Ureteral
- Decision date
- 2025-05-22
- Date received
- 2025-03-26
- 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: K250910.pdf
Official FDA record: K250910
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.