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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Gastro-Enterostomy
510(k) Number K182832
Device Name Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact Kotei Aoki
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact Rohini Patel
Regulation Number876.5980
Classification Product Code
KGC  
Subsequent Product Code
FGE  
Date Received10/09/2018
Decision Date 06/26/2019
Decision Substantially Equivalent - Kit (SESK)
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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