FDA product code MZM: Fibrin Sealant Preparation Device
MZM is the FDA product code for fibrin sealant preparation device. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the Hematology panel. Devices under MZM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Fibrin Sealant Preparation Device |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HE — Hematology |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for MZM devices
openFDA lists no recalls for product code MZM.
Frequently asked questions
What is FDA product code MZM?
MZM is the FDA product code for fibrin sealant preparation device. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the Hematology panel.
What device class is MZM?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code MZM
- Run a recall and safety report across every MZM manufacturer
- Watch product code MZM 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.