Cleared Traditional

G-Vitri? Vitrification Straw

K240002 · Gimbo Medical Technology Shenzhen Co., Ltd. · Obstetrics & Gynecology
Jun 2024
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K240002 is an FDA 510(k) clearance for the G-Vitri? Vitrification Straw, a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Gimbo Medical Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 14, 2024, 164 days after receiving the submission on January 2, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.

Submission Details

510(k) Number K240002 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2024
Decision Date June 14, 2024
Days to Decision 164 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MQK — Labware, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6160

Similar Devices — MQK Labware, Assisted Reproduction

All 49
SperSort? Sperm Sorting Chip (IPG02)
K241626 · Ipreg Incorporation · Feb 2025
Minvitro? Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
K241454 · Guangzhou Hehong Biotech Co., Ltd. · Feb 2025
SwimCount? Harvester (1 mL); SwimCount? Harvester (3 mL)
K241348 · Motilitycount Aps · Jan 2025
cryo-GO Vitrification Device
K241341 · Fujifilm Irvine Scientific · Sep 2024
SpermAlign Sperm Separation Device
K232980 · Cytoswim, Ltd. · Mar 2024
Nest VT Vitrification Device
K233177 · Cook Incorporated · Mar 2024