510(k) K212846

Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use by Jiangsu Jichun Medical Devices Co., Ltd. — Product Code FMF

K212846 is an FDA 510(k) premarket notification submitted by Jiangsu Jichun Medical Devices Co., Ltd. for the device "Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use". The FDA issued a decision of Substantially Equivalent on Aug 30, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.