510(k) K222124

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code FMI

K222124 is an FDA 510(k) premarket notification submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. for the device "Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle". The FDA issued a decision of Substantially Equivalent on November 4, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has at least 10 other 510(k) clearances on record.