510(k) K010056

UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450 by A & A Medical, Inc. — Product Code LKF

K010056 is an FDA 510(k) premarket notification submitted by A & A Medical, Inc. for the device "UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. A & A Medical, Inc. has at least 10 other 510(k) clearances on record.