K242561

Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)

510(k) number: K242561
Device name: Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
Applicant: Donnevie Medical Technology (Shanghai) Co. , Ltd. CN
Product code: MQL — Media, Reproductive
Decision date: 2025-04-10
Date received: 2024-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

Also available from FDA: K242561.pdf

Official FDA record: K242561

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