510(k) K171984

Clickfine Pen Needle, Penfine Classic Pen Needle by Ypsomed AG — Product Code FMI

K171984 is an FDA 510(k) premarket notification submitted by Ypsomed AG for the device "Clickfine Pen Needle, Penfine Classic Pen Needle". The FDA issued a decision of Substantially Equivalent on October 11, 2017. 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.