510(k) K231720

Sterile Hypodermic Needles for Single Use by Wepon Medical Technology Co., Ltd. — Product Code FMI

K231720 is an FDA 510(k) premarket notification submitted by Wepon Medical Technology Co., Ltd. for the device "Sterile Hypodermic Needles for Single Use". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Wepon Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.