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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 K261342
Device Name Urocross Expander System (UES-2018-C1)
Applicant
Prodeon Medical, Inc.
2200 Zanker Rd., Unit F
San Jose,  CA  95131
Applicant Contact Elaine Aplaon
Correspondent
Prodeon Medical, Inc.
2200 Zanker Rd., Unit F
San Jose,  CA  95131
Correspondent Contact Elaine Aplaon
Classification Product Code
QKA  
Date Received04/23/2026
Decision Date 06/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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