# PAJ: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2000: 1
- 2005: 1

## Most-cited predicates
- K002233: Bvi Sling (2000), cited by 1
- K051190: Xenform Soft Tissue Repair Matrix (2005), cited by 1

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