# MES: Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- Recalls: 0 (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)
- 2001: 2
- 2003: 2
- 2004: 2
- 2006: 1
- 2007: 3
- 2008: 2
- 2009: 1
- 2010: 3
- 2011: 2
- 2012: 1

## Most-cited predicates

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