510(k) K211214

Sterile Hypodermic Needles for Single Use by Azur Medical Company, Inc. — Product Code FMI

K211214 is an FDA 510(k) premarket notification submitted by Azur Medical Company, Inc. for the device "Sterile Hypodermic Needles for Single Use". The FDA issued a decision of Substantially Equivalent on October 14, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Azur Medical Company, Inc. has at least 3 other 510(k) clearances on record.