510(k) K220900

Safety Blood Collection Needles with/without Needle Holder by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code JKA

K220900 is an FDA 510(k) premarket notification submitted by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. for the device "Safety Blood Collection Needles with/without Needle Holder". The FDA issued a decision of Substantially Equivalent on August 10, 2022. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. has at least 10 other 510(k) clearances on record.