Urocross Expander System (Model Numbers ES2018 and ES3025)— 510(k) K253525
Substantially EquivalentProdeon Medical, Inc.
FDA 510(k) clearance K253525 for Urocross Expander System (Model Numbers ES2018 and ES3025), Substantially Equivalent on 2026-03-12. Applicant: Prodeon Medical, Inc.. Device class: 2.
Summary
Prodeon Medical's Urocross Expander System is filed under QKA, temporarily-placed urethral opening systems for symptoms of benign prostatic hyperplasia. The name gives two model numbers, ES2018 and ES3025.
Class II, 21 CFR 876.5510. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Prodeon Medical filed from Sunnyvale, California. The decision came 119 calendar days after receipt (November 13, 2025 to March 12, 2026).
Clearance details
- Applicant
- Prodeon Medical, Inc.
- Product code
- Product code QKA
- Device class
- Class 2
- Regulation
- 21 CFR 876.5510
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
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