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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K261141
Device Name OpenFlo Urinary Catheter
Applicant
Urolution Medical, Inc.
10550 County Rd. 81, Suite 219
Maple Grove,  MN  55369
Applicant Contact Darin Busch
Correspondent
Urolution Medical, Inc.
10550 County Rd. 81, Suite 219
Maple Grove,  MN  55369
Correspondent Contact Darin Busch
Regulation Number876.5130
Classification Product Code
EZL  
Date Received04/07/2026
Decision Date 10/06/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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