510(k) K213478

BD Pen Needle by Becton, Dickinson And Company — Product Code FMI

K213478 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company for the device "BD Pen Needle". The FDA issued a decision of Substantially Equivalent on Jun 28, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Becton, Dickinson And Company has 329 other 510(k) clearances on record.