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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K213283
Device Name GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
Applicant
Convatec Limited
Gdc, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Applicant Contact Louise Hollywood
Correspondent
Convatec Limited
Gdc, First Ave., Deeside Industrial Park
Deeside,  GB CH5 2NU
Correspondent Contact Louise Hollywood
Regulation Number876.5130
Classification Product Code
GBM  
Date Received10/01/2021
Decision Date 06/22/2022
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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