510(k) K170898

Wittich Nitinol Stone Basket by Cook Incorporated — Product Code LQR

K170898 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Wittich Nitinol Stone Basket". The FDA issued a decision of Substantially Equivalent on Dec 12, 2017. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Cook Incorporated has at least 10 other 510(k) clearances on record.