Urocross Expander System (UES-2018-C1)— 510(k) K261342
Substantially EquivalentProdeon Medical, Inc.
FDA 510(k) clearance K261342 for Urocross Expander System (UES-2018-C1), Substantially Equivalent on 2026-06-22. Applicant: Prodeon Medical, Inc.. Device class: 2.
Summary
Prodeon Medical's Urocross Expander System (UES-2018-C1) is filed under QKA, which the code name gives as temporarily-placed urethral opening systems for symptoms of benign prostatic hyperplasia. The record doesn't describe the system beyond the model number and the code name.
Class II, 21 CFR 876.5510. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Prodeon filed from San Jose, California. The decision came 60 calendar days after FDA received it (April 23 to June 22, 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
- San Jose, CA, US
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