510(k) K212805

SteriCap Mini Needle and Standard Needles by Ocuject, LLC — Product Code FMI

K212805 is an FDA 510(k) premarket notification submitted by Ocuject, LLC for the device "SteriCap Mini Needle and Standard Needles". The FDA issued a decision of Substantially Equivalent on September 30, 2021. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ocuject, LLC has at least 7 other 510(k) clearances on record.