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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter, G-U
510(k) Number K260919
Device Name Transurethral Catheter Safety Valve (TUCSV) (80050)
Applicant
Class Medical , Ltd.
Unit 1d Annacotty Business Park
Annacotty
Co Limerick,  IE
Applicant Contact Danny Forde
Correspondent
RQM+
5000 Centregreen Way
Suite 100
Cary,  NC  27513
Correspondent Contact David Worrell
Regulation Number876.5130
Classification Product Code
KNY  
Date Received03/19/2026
Decision Date 08/05/2026
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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