510(k) K160170

Lehman Manometry Catheter by Wilson-Cook Medical, Inc. — Product Code FFX

K160170 is an FDA 510(k) premarket notification submitted by Wilson-Cook Medical, Inc. for the device "Lehman Manometry Catheter". The FDA issued a decision of Substantially Equivalent on June 20, 2016. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Wilson-Cook Medical, Inc. has at least 10 other 510(k) clearances on record.