510(k) K092016

SUPER-FINE PEN NEEDLE by Stat Medical Devices, Inc. — Product Code FMI

K092016 is an FDA 510(k) premarket notification submitted by Stat Medical Devices, Inc. for the device "SUPER-FINE PEN NEEDLE". The FDA issued a decision of Substantially Equivalent on October 2, 2009. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Stat Medical Devices, Inc. has at least 3 other 510(k) clearances on record.