510(k) K233343

SteriCap Safety Needle; VitreJect Safety Needle by Ocuject, LLC — Product Code FMI

K233343 is an FDA 510(k) premarket notification submitted by Ocuject, LLC for the device "SteriCap Safety Needle; VitreJect Safety Needle". The FDA issued a decision of Substantially Equivalent on November 27, 2023. 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.