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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K260737
Device Name Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).
Applicant
Convatec
First Ave., Deeside Industrial Estate
Deeside
Flintshire,  GB CH5 2NU
Applicant Contact Kim Jones
Correspondent
Convatec
First Ave., Deeside Industrial Estate
Deeside
Flintshire,  GB CH5 2NU
Correspondent Contact Kim Jones
Regulation Number876.5130
Classification Product Code
EZD  
Date Received03/06/2026
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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