510(k) K211555

Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code MEG

K211555 is an FDA 510(k) premarket notification submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. for the device "Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe". The FDA issued a decision of Substantially Equivalent on October 18, 2021. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has at least 10 other 510(k) clearances on record.