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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
510(k) Number K253525
Device Name Urocross Expander System (Model Numbers ES2018 and ES3025)
Applicant
Prodeon Medical, Inc.
452 Oakmead Pkwy.
Sunnyvale,  CA  94085
Applicant Contact Elaine Aplaon
Correspondent
Prodeon Medical, Inc.
452 Oakmead Pkwy.
Sunnyvale,  CA  94085
Correspondent Contact Elaine Aplaon
Classification Product Code
QKA  
Date Received11/13/2025
Decision Date 03/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT05400980
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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