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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K173035
Device Name Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
Applicant
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Applicant Contact Erum B. Nasir
Correspondent
Cook Incorporated
750 Daniels Way
Bloomington,  IN  47402
Correspondent Contact Erum B. Nasir
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Codes
GBO   LJE  
Date Received09/28/2017
Decision Date 05/01/2018
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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