FDA Product Code MQH: Microtools, Assisted Reproduction (pipettes)

FDA 510(k) Cleared Microtools, Assisted Reproduction (pipettes) Devices (Product Code MQH)

About Product Code MQH - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code MQH since 1999, with 26 receiving FDA clearance (average review time: 153 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MQH Product Code

Recent submissions under MQH have taken an average of 105 days to reach a decision - down from 155 days historically, suggesting improved FDA processing for this classification.

MQH devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →

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