510(k) K171915

Nathanson Transcystic Bile Duct Stone Exploration Pack by Cook Incorporated — Product Code LQR

K171915 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Nathanson Transcystic Bile Duct Stone Exploration Pack". The FDA issued a decision of Substantially Equivalent on March 1, 2018. 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.