Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])

About This 510(k) Submission

K251637 is an FDA 510(k) clearance for the Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]), a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Donnevie Medical Technology (Shanghai) Co. , Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 27, 2025, 90 days after receiving the submission on May 29, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.