510(k) K183665

Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use by Jiangsu Micsafe Medical Technology Co., Ltd. — Product Code MEG

K183665 is an FDA 510(k) premarket notification submitted by Jiangsu Micsafe Medical Technology Co., Ltd. for the device "Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use". The FDA issued a decision of Substantially Equivalent on September 6, 2019. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860. Jiangsu Micsafe Medical Technology Co., Ltd. has at least 4 other 510(k) clearances on record.