510(k) K212857

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use by Jiangsu Zhiyu Medical Instrument Co, Ltd. — Product Code FMF

K212857 is an FDA 510(k) premarket notification submitted by Jiangsu Zhiyu Medical Instrument Co, Ltd. for the device "Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use". The FDA issued a decision of Substantially Equivalent on May 9, 2023. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.