510(k) K230635

Pen Needle by Jiangsu Caina Medical Co.,Ltd — Product Code FMI

K230635 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Pen Needle". The FDA issued a decision of Substantially Equivalent on June 2, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.