510(k) K022415

BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST by Waismed, Ltd. — Product Code FMI

K022415 is an FDA 510(k) premarket notification submitted by Waismed, Ltd. for the device "BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Waismed, Ltd. has at least 6 other 510(k) clearances on record.