# LNM: Agent, Bulking, Injectable For Gastro-Urology Use

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 9
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 7
- 2018: 7
- 2019: 10
- 2020: 23
- 2021: 5
- 2022: 13
- 2023: 14
- 2024: 8
- 2025: 7
- 2026: 7

## Most-cited predicates

Source page: https://510kreport.com/product-code/LNM
Data by year (CSV): https://510kreport.com/product-code/LNM.csv