510(k) K181447

Safety insulin needle for single use by Berpu Medical Technology Co., Ltd. — Product Code FMI

K181447 is an FDA 510(k) premarket notification submitted by Berpu Medical Technology Co., Ltd. for the device "Safety insulin needle for single use". The FDA issued a decision of Substantially Equivalent on March 12, 2019. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Berpu Medical Technology Co., Ltd. has at least 8 other 510(k) clearances on record.