510(k) K171969

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 by Wilson-Cook Medical, Inc. — Product Code LQR

K171969 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "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". The FDA issued a decision of Substantially Equivalent on March 28, 2018. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2018
Date Received
June 30, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type