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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K233411
Device Name Folysil Silicone Catheter
Applicant
Coloplast Corp.
1601 W. River Rd. N.
Plymouth,  MN  55411
Applicant Contact Brian Schmidt
Correspondent
Kompass Regulatory Consulting
1583 Northrop St.
Falcon Heights,  MN  55108
Correspondent Contact Kristen Swanson
Regulation Number876.5130
Classification Product Code
EZL  
Date Received10/06/2023
Decision Date 04/15/2024
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
Recalls CDRH Recalls
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