Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more— 510(k) K251637

Name: FDA 510(k) clearance K251637
Creator: U.S. Food and Drug Administration
Published: 2025-08-27

Substantially Equivalent

Donnevie Medical Technology (Shanghai) Co. , Ltd.

FDA 510(k) clearance K251637 for Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] +1 more, Substantially Equivalent on 2025-08-27. Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Device class: 2.

Clearance details

Device name as filed: 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.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2025-05-29
Decision date: 2025-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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