510(k) K193526

Syringe with safety needle, Safety needle by Jiangsu Caina Medical Co.,Ltd — Product Code FMF

K193526 is an FDA 510(k) premarket notification submitted by Jiangsu Caina Medical Co.,Ltd for the device "Syringe with safety needle, Safety needle". The FDA issued a decision of Substantially Equivalent on July 17, 2020. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Jiangsu Caina Medical Co.,Ltd has at least 10 other 510(k) clearances on record.