510(k) K233037

Sterile Hypodermic Needles for Single Use by Zhejiang Kindly Medical Device Co., Ltd. — Product Code FMI

K233037 is an FDA 510(k) premarket notification submitted by Zhejiang Kindly Medical Device Co., Ltd. for the device "Sterile Hypodermic Needles for Single Use". The FDA issued a decision of Substantially Equivalent on December 12, 2023. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Zhejiang Kindly Medical Device Co., Ltd. has at least 1 other 510(k) clearance on record.