FDA product code LNM: Agent, Bulking, Injectable For Gastro-Urology Use
LNM is the FDA product code for agent, bulking, injectable for gastro-urology use. It is a Class III device, reviewed by the Gastroenterology and Urology panel. Devices under LNM reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 3 recalls for LNM devices.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Bulking, Injectable For Gastro-Urology Use |
| Device class | Class III |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LNM devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-06-03.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code LNM?
LNM is the FDA product code for agent, bulking, injectable for gastro-urology use. It is a Class III device, reviewed by the Gastroenterology and Urology panel.
What device class is LNM?
Class III. Typical premarket route: PMA.
Have LNM devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2021-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LNM
- Run a recall and safety report across every LNM manufacturer
- Watch product code LNM 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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