510(k) K182381

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

K182381 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Wilson-Cook Mini Basket". The FDA issued a decision of Substantially Equivalent on October 30, 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
October 30, 2018
Date Received
August 31, 2018
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