FDA product code MNQ: Stimulator, Hypoglossal Nerve, Implanted, Apnea
MNQ is the FDA product code for stimulator, hypoglossal nerve, implanted, apnea. It is a Class III device, reviewed by the Anesthesiology panel. Devices under MNQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 6 recalls for MNQ devices, 5 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Hypoglossal Nerve, Implanted, Apnea |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MNQ devices
6 product recalls in 4 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-05-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2024 | 3 |
| 2026 | 2 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C8009 — Removal of hypoglossal nerve neurostimulator array and pulse generator
Frequently asked questions
What is FDA product code MNQ?
MNQ is the FDA product code for stimulator, hypoglossal nerve, implanted, apnea. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is MNQ?
Class III. Typical premarket route: PMA.
Have MNQ devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2026-05-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MNQ
- Run a recall and safety report across every MNQ manufacturer
- Watch product code MNQ 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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