FDA product code MXP: Bone Particle Collector
MXP is the FDA product code for bone particle collector. It is a Class I device, regulated under 21 CFR 874.4800 and reviewed by the Ear, Nose and Throat panel. Devices under MXP reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 3 recalls for MXP devices.
Classification
| Field | Value |
|---|---|
| Device name | Bone Particle Collector |
| Device class | Class I |
| Regulation | 21 CFR 874.4800 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for MXP devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 3 still open. Most recent: 2020-12-07.
| Year | Recalls |
|---|---|
| 2020 | 3 |
Frequently asked questions
What is FDA product code MXP?
MXP is the FDA product code for bone particle collector. It is a Class I device, regulated under 21 CFR 874.4800 and reviewed by the Ear, Nose and Throat panel.
What device class is MXP?
Class I, regulation 21 CFR 874.4800. Typical premarket route: 510(k) exempt.
Have MXP devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2020-12-07.
Next steps
- Run an FDA pathway report with predicate devices for product code MXP
- Run a recall and safety report across every MXP manufacturer
- Watch product code MXP 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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