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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 K250699
Device Name Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)
Applicant
Convatec
First Ave., Deeside Industrial Estate
Deeside
Flintshire,  GB CH5 2NU
Applicant Contact Cole Langham
Correspondent
Convatec
First Ave., Deeside Industrial Estate
Deeside
Flintshire,  GB CH5 2NU
Correspondent Contact Cole Langham
Regulation Number876.5130
Classification Product Code
EZD  
Date Received03/07/2025
Decision Date 07/01/2025
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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