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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K181811
Device Name ReTrace Ureteral Access Sheath
Applicant
Coloplast A/S
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Cori Ragan
Correspondent
Coloplast A/S
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Cori Ragan
Regulation Number876.1500
Classification Product Code
FED  
Date Received07/06/2018
Decision Date 09/07/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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