510(k) K221066

Sterile Hypodermic Needles for Single Use by Sichuan Prius Biotechnology Co., Ltd. — Product Code FMI

K221066 is an FDA 510(k) premarket notification submitted by Sichuan Prius Biotechnology Co., Ltd. for the device "Sterile Hypodermic Needles for Single Use". The FDA issued a decision of Substantially Equivalent on October 4, 2022. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Sichuan Prius Biotechnology Co., Ltd. has at least 8 other 510(k) clearances on record.