FDA product code MZR: Topical Approximation System
MZR is the FDA product code for topical approximation system. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General Hospital panel. Devices under MZR reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Topical Approximation System |
| Device class | Class I |
| Regulation | 21 CFR 880.5240 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Recalls for MZR devices
openFDA lists no recalls for product code MZR.
Frequently asked questions
What is FDA product code MZR?
MZR is the FDA product code for topical approximation system. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General Hospital panel.
What device class is MZR?
Class I, regulation 21 CFR 880.5240. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code MZR
- Run a recall and safety report across every MZR manufacturer
- Watch product code MZR 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.
All General Hospital product codes · FDA product code lookup