Cleared Traditional

K234023 - Oocyte Flushing & Retrieval Medium

Also marketed or referenced as:
Gamete Buffer

K234023 is an FDA 510(k) clearance for Oocyte Flushing & Retrieval Medium, 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 142-day FDA review.

K234023 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
142d
Days
Class 2
Risk

K234023 is an FDA 510(k) clearance for the Oocyte Flushing & Retrieval Medium. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shezhen, CN). The FDA issued a Cleared decision on May 10, 2024 after a review of 142 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 - K234023

510(k) Number K234023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2023
Decision Date May 10, 2024
Days to Decision 142 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
18d faster than avg
Panel avg: 160d · This submission: 142d
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 K234023.
Ultra RapidWarm™ Blast
K240605 · Vitrolife Sweden AB · Aug 2024
Cryo-straw (Type I, Type III)
K233477 · Shandong Wego Ruisheng Medical Device Co., Ltd. · Jul 2024
Giftlife™ Fertilization Medium
K240149 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jun 2024
SSS-NX (Serum Substitute Supplement-NX)
K233764 · Fujifilm Irvine Scientific · Apr 2024
V-PVP
K232125 · Vitromed GmbH · Mar 2024
G-Vitri™ Vitrification Freeze Media
K232942 · Gimbo Medical Technology Shenzhen Co., Ltd. · Jan 2024