510(k) K150662

Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) by Ypsomed AG — Product Code FMI

K150662 is an FDA 510(k) premarket notification submitted by Ypsomed AG for the device "Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)". The FDA issued a decision of Substantially Equivalent on June 9, 2015. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ypsomed AG has at least 10 other 510(k) clearances on record.