FDA Product Code MQG: Accessory, Assisted Reproduction
Leading manufacturers include Genea Biomedx Pty, Ltd., Vitrolife A/S and Wuhan Huchuang Union Technology Co., Ltd..
FDA 510(k) Cleared Accessory, Assisted Reproduction Devices (Product Code MQG)
About Product Code MQG - Regulatory Context
510(k) Submission Activity
46 total 510(k) submissions under product code MQG since 1998, with 46 receiving FDA clearance (average review time: 165 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MQG Product Code
FDA review times for MQG submissions have been consistent, averaging 177 days recently vs 165 days historically.
MQG devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →