510(k) K173009

NCompass Nitinol Stone Extractors by Cook Incorporated — Product Code LQR

K173009 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "NCompass Nitinol Stone Extractors". The FDA issued a decision of Substantially Equivalent on November 7, 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.