FDA product code MNB: Device, Thermal Ablation, Endometrial
MNB is the FDA product code for device, thermal ablation, endometrial. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MNB reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 12 recalls for MNB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Device, Thermal Ablation, Endometrial |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for MNB devices
12 product recalls in 7 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-03-20.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MNB?
MNB is the FDA product code for device, thermal ablation, endometrial. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is MNB?
Class III. Typical premarket route: PMA.
Have MNB devices been recalled?
Yes: 12 product recalls across 7 recall events; the most recent began 2025-03-20.
Next steps
- Run an FDA pathway report with predicate devices for product code MNB
- Run a recall and safety report across every MNB manufacturer
- Watch product code MNB 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 Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times