# PAG: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 9
- 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)
- 1998: 1
- 1999: 2
- 2002: 1
- 2003: 2
- 2004: 1
- 2005: 1
- 2009: 1

## Most-cited predicates
- K992159: Surgisis Sling (1999), cited by 13
- K050445: Ams Collagen Dermal Matrix (2005), cited by 3
- K993459: Modification to Brennen Biosynthetic Surgical Mesh Matrix (1999), cited by 3
- K030460: Modification to Brennen Biosynthetic Surgical Mesh Matrix (2003), cited by 2
- K982403: Brennen Biosynthetic Surgical Mesh Matrix (1998), cited by 2

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