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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K161344
Device Name GentleCath Glide Intermittent Catheter
Applicant
Convatec Limited
Gdc, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Applicant Contact ELINOR JONES
Correspondent
Convatec Limited
Gdc, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Correspondent Contact ELINOR JONES
Regulation Number876.5130
Classification Product Code
KOD  
Subsequent Product Code
GBM  
Date Received05/13/2016
Decision Date 09/20/2016
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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