FDA product code MCP: Stimulator, Fetal, Acoustic
MCP is the FDA product code for stimulator, fetal, acoustic. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MCP reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Fetal, Acoustic |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MCP devices
openFDA lists no recalls for product code MCP.
Frequently asked questions
What is FDA product code MCP?
MCP is the FDA product code for stimulator, fetal, acoustic. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MCP?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MCP
- Run a recall and safety report across every MCP manufacturer
- Watch product code MCP 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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