Cleared Traditional

Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])

K212426 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Obstetrics & Gynecology
Jun 2022
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K212426 is an FDA 510(k) clearance for the Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage 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 June 16, 2022, 316 days after receiving the submission on August 4, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K212426 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2021
Decision Date June 16, 2022
Days to Decision 316 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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