Cleared Traditional

K232942 - G-Vitri Vitrification Freeze Media

Also marketed or referenced as:
G-Vitri™ Vitrification Thawing Media

K232942 is an FDA 510(k) clearance for G-Vitri Vitrification Freeze Media, manufactured by Gimbo Medical Technology Shenzhen Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

K232942 is an FDA 510(k) clearance for the G-Vitri™ Vitrification Freeze Media. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 30, 2024 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gimbo Medical Technology Shenzhen Co., Ltd. devices

FDA 510(k) Submission Details - K232942

510(k) Number K232942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 160d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQL Device Classification - Class 2, Special Controls

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQL Media, Reproductive

All 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K232942.
Oocyte Flushing & Retrieval Medium
K234023 · Gimbo Medical Technology Shenzhen Co., Ltd. · May 2024
SSS-NX (Serum Substitute Supplement-NX)
K233764 · Fujifilm Irvine Scientific · Apr 2024
V-PVP
K232125 · Vitromed GmbH · Mar 2024
Dewin Blastocyst Medium (with HSA and without HSA)
K231370 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Aug 2023
V-HYADASE
K222606 · Vitromed GmbH · May 2023
CryoX Vitrification Freeze Kit / Thaw Kit
K223265 · Zhejiang Horizon Medical Technology Co., Ltd. · May 2023