510(k) K172846

Uterine Manipulator by Beijing Hangtian Kadi Technology R&D Institute — Product Code LKF

K172846 is an FDA 510(k) premarket notification submitted by Beijing Hangtian Kadi Technology R&D Institute for the device "Uterine Manipulator". The FDA issued a decision of Substantially Equivalent on June 26, 2018. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Beijing Hangtian Kadi Technology R&D Institute has at least 1 other 510(k) clearance on record.