FDA product code MQI: Microtool Fabrication, Assisted Reproduction
MQI is the FDA product code for microtool fabrication, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6140 and reviewed by the Obstetrics and Gynecology panel. Devices under MQI reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Microtool Fabrication, Assisted Reproduction |
| Device class | Class II |
| Regulation | 21 CFR 884.6140 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for MQI devices
openFDA lists no recalls for product code MQI.
Frequently asked questions
What is FDA product code MQI?
MQI is the FDA product code for microtool fabrication, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6140 and reviewed by the Obstetrics and Gynecology panel.
What device class is MQI?
Class II, regulation 21 CFR 884.6140. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MQI
- Run a recall and safety report across every MQI manufacturer
- Watch product code MQI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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