FDA product code LMG: Agent, Absorbable Hemostatic, Non-Collagen Based
LMG is the FDA product code for agent, absorbable hemostatic, non-collagen based. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel. Devices under LMG reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 4 recalls for LMG devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Absorbable Hemostatic, Non-Collagen Based |
| Device class | Class III |
| Regulation | 21 CFR 878.4490 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | PMA |
| Implant | Yes |
Recalls for LMG devices
4 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2024 | 2 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code LMG?
LMG is the FDA product code for agent, absorbable hemostatic, non-collagen based. It is a Class III device, regulated under 21 CFR 878.4490 and reviewed by the General and Plastic Surgery panel.
What device class is LMG?
Class III, regulation 21 CFR 878.4490. Typical premarket route: PMA.
Have LMG devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LMG
- Run a recall and safety report across every LMG manufacturer
- Watch product code LMG 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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