510(k) K251637

Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) by Donnevie Medical Technology (Shanghai) Co. , Ltd. — Product Code MQL

K251637 is an FDA 510(k) premarket notification submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. for the device "Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])". The FDA issued a decision of Substantially Equivalent on August 27, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Donnevie Medical Technology (Shanghai) Co. , Ltd. has at least 3 other 510(k) clearances on record.