K253525
- 510(k) number
- K253525
- Device name
- Urocross Expander System (Model Numbers ES2018 and ES3025)
- Applicant
- Prodeon Medical, Inc. CA · US
- Product code
- QKA — Temporarily-Placed Urethral Opening System For Sympt
- Decision date
- 2026-03-12
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253525.pdf
Official FDA record: K253525
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.