510(k) K010296

UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 by Marina Medical Instruments, Inc. — Product Code LKF

K010296 is an FDA 510(k) premarket notification submitted by Marina Medical Instruments, Inc. for the device "UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450". The FDA issued a decision of Substantially Equivalent on April 11, 2001. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Marina Medical Instruments, Inc. has at least 4 other 510(k) clearances on record.