510(k) K153706

Insulin Pen Needle by SteriLance Medical (Suzhou), Inc. — Product Code FMI

K153706 is an FDA 510(k) premarket notification submitted by SteriLance Medical (Suzhou), Inc. for the device "Insulin Pen Needle". The FDA issued a decision of Substantially Equivalent on August 29, 2016. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. SteriLance Medical (Suzhou), Inc. has at least 9 other 510(k) clearances on record.