
Prodeon Medical, Inc.
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Urocross Expander System (Model Numbers ES2018 and ES3025) is an FDA 510(k)-cleared medical device (K253525) manufactured by Prodeon Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 11, 2026. Regulation: 8.