Cleared Traditional

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

K242561 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Obstetrics & Gynecology
Apr 2025
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K242561 is an FDA 510(k) clearance for the Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit), 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 April 10, 2025, 225 days after receiving the submission on August 28, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K242561 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2024
Decision Date April 10, 2025
Days to Decision 225 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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