Cleared Traditional

Giftlife? Fertilization Medium; Giftlife? Cleavage Medium; Giftlife? Blastocyst Medium; Giftlife? Single Step Medium

K240149 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology
Jun 2024
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K240149 is an FDA 510(k) clearance for the Giftlife? Fertilization Medium; Giftlife? Cleavage Medium; Giftlife? Blastocyst Medium; Giftlife? Single Step Medium, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 13, 2024, 146 days after receiving the submission on January 19, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K240149 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2024
Decision Date June 13, 2024
Days to Decision 146 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

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

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