Cleared Traditional

Sperm Freezing Medium

K242043 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology
Jan 2025
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K242043 is an FDA 510(k) clearance for the Sperm Freezing 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 January 8, 2025, 180 days after receiving the submission on July 12, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K242043 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2024
Decision Date January 08, 2025
Days to Decision 180 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

Similar Devices — MQL Media, Reproductive

All 257
CaseBio? Culture w/HSA (CMH5); CaseBio? Handling w/HSA (WHH5)
K252672 · Casebioscience, Inc. · Feb 2026
Fast Warm - NX
K250445 · Fujifilm Irvine Scientific · Sep 2025
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
K251637 · Donnevie Medical Technology (Shanghai) Co. , Ltd. · Aug 2025
Ultra-Fast Vitri; Ultra-Fast Warm
K251305 · Kitazato Corporation · Aug 2025
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
K242640 · Fertipro NV · May 2025
Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
K242089 · Jiangsu Ruifuda Medical Device Co., Ltd. · Apr 2025