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])

510(k) number: K251637
Device name: Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd. CN
Product code: MQL — Media, Reproductive
Decision date: 2025-08-27
Date received: 2025-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K251637.pdf

Official FDA record: K251637

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.