Cleared Traditional

G-Vitri? Vitrification Freeze Media; G-Vitri? Vitrification Thawing Media

K232942 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology
Jan 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K232942 is an FDA 510(k) clearance for the G-Vitri? Vitrification Freeze Media; G-Vitri? Vitrification Thawing Media, 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 January 30, 2024, 132 days after receiving the submission on September 20, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K232942 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2023
Decision Date January 30, 2024
Days to Decision 132 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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