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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dislodger, Stone, Biliary
510(k) Number K171969
Device Name Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Applicant Contact Ashley Howard
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Rd.
Winston-Salem,  NC  27105
Correspondent Contact Ashley Howard
Regulation Number876.5010
Classification Product Code
LQR  
Date Received06/30/2017
Decision Date 03/28/2018
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
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