# OTO: Mesh, Surgical, 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: 23
- 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)
- 2004: 1
- 2005: 2
- 2006: 1
- 2009: 1
- 2011: 1
- 2012: 7
- 2013: 4
- 2014: 1
- 2015: 2
- 2017: 1

## Most-cited predicates
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair (2002), cited by 6
- K041632: Minimesh Polypropylene Mesh (2004), cited by 6
- K051485: Ams Pelvic Floor Repair System (2005), cited by 5
- K010931: Ams Sacral Colpopexy Sling, Model 72403501 (2001), cited by 3
- K053361: Modification to: Minimesh Polypropylene Mesh (2006), cited by 3
- K112322: Restorelle Polypropylene Y Mesh (2012), cited by 3
- K120327: Vertessa (2012), cited by 3
- K101722: Alyte Y-Mesh Graft (2011), cited by 3
- K051245: Polyform Synthetic Mesh (2005), cited by 2
- K140116: Restorelle Y Contour Mesh (2014), cited by 1

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