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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Catheter, Ureteral
510(k) Number K250910
Device Name Optilume® High Pressure Urological Balloon Dilation Catheter
Applicant
Urotronic, Inc.
2495 Xenium Lane N.
Minneapolis,  MN  55441
Applicant Contact Alex Zuniga
Correspondent
Urotronic, Inc.
2495 Xenium Lane N.
Minneapolis,  MN  55441
Correspondent Contact Alex Zuniga
Regulation Number876.5470
Classification Product Code
EZN  
Subsequent Product Code
KOE  
Date Received03/26/2025
Decision Date 05/22/2025
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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