# MIP: Implanted Fecal Incontinence Device

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- Recalls: 1 (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)
- 2007: 3
- 2008: 5
- 2009: 3
- 2010: 4
- 2011: 1
- 2012: 6
- 2013: 1
- 2014: 1
- 2015: 4
- 2016: 1

## Most-cited predicates

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