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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K173355
Device Name Gastric Sizing Balloon Catheter
Applicant
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Colin Jacobs
Correspondent
Cook Incorporated
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Colin Jacobs
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/25/2017
Decision Date 11/17/2017
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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