Urocross Expander System (UES-2018-C1)— 510(k) K261342

Name: FDA 510(k) clearance K261342
Creator: U.S. Food and Drug Administration
Published: 2026-06-22

Substantially Equivalent

Prodeon 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.

Clearance details

Applicant: Prodeon Medical, Inc.
Product code: Code QKA
Device class: Class 2
Regulation: 21 CFR 876.5510
Advisory panel: Gastroenterology, Urology
Date received: 2026-04-23
Decision date: 2026-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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