FDA product code MGR: Dressing, Wound And Burn, Interactive
MGR is the FDA product code for dressing, wound and burn, interactive. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under MGR reach the market by PMA; FDA lists no cleared 510(k)s for it. 5 PMA applications cite this product code. FDA has posted 7 recalls for MGR devices.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound And Burn, Interactive |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MGR devices
7 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-02-21.
Frequently asked questions
What is FDA product code MGR?
MGR is the FDA product code for dressing, wound and burn, interactive. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is MGR?
Class III. Typical premarket route: PMA.
Have MGR devices been recalled?
Yes: 7 product recalls across 7 recall events; the most recent began 2011-02-21.
Next steps
- Run an FDA pathway report with predicate devices for product code MGR
- Run a recall and safety report across every MGR manufacturer
- Watch product code MGR 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 and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times