510(k) K221308

Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle by Jiangxi Maidikang Medical Devices Co., Ltd. — Product Code FMF

K221308 is an FDA 510(k) premarket notification submitted by Jiangxi Maidikang Medical Devices Co., Ltd. for the device "Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle". The FDA issued a decision of Substantially Equivalent on Oct 17, 2022. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860.