Clearance Summary
Urocross Expander System (Model Numbers ES2018 and ES3025) received FDA 510(k) clearance under submission number K253525, sponsored by Prodeon Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-03-12.
- Submission: K253525
- Applicant / Sponsor: Prodeon Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5510
- Decision date: 2026-03-12
Classification & Regulation
This clearance is catalogued under FDA product code QKA and 21 CFR 876.5510, within the Gastroenterology, Urology review panel as a Class II device.