510(k) K213146

Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen by Jiangsu Rongye Technology Co., Ltd. — Product Code JKA

K213146 is an FDA 510(k) premarket notification submitted by Jiangsu Rongye Technology Co., Ltd. for the device "Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675.