510(k) K163214

Unicare System, Unicare Manipulator by Clearpath Surgical, Inc. — Product Code LKF

K163214 is an FDA 510(k) premarket notification submitted by Clearpath Surgical, Inc. for the device "Unicare System, Unicare Manipulator". The FDA issued a decision of Substantially Equivalent on February 7, 2017. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530.