# OTP: Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

- Device class: 3; regulation: 21 CFR 884.5980; FDA's rule: PMA required
- FDA decisions: 31
- 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)
- 2003: 1
- 2004: 3
- 2005: 2
- 2007: 4
- 2008: 8
- 2009: 6
- 2011: 5
- 2012: 2

## Most-cited predicates
- K040623: Ams Perigee System (2004), cited by 5
- K033636: Ams Large Pore Polypropylene Mesh (2003), cited by 5
- K040537: Ams Apogee Vault Suspension System (2004), cited by 5
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems (2008), cited by 5
- K040521: Modification to Ams Large Pore Polypropylene Mesh (2004), cited by 4
- K092207: Restorelle Polypropylene Mesh (2009), cited by 4
- K063712: Avaulta Support System/Avaulta Plus Biosynthetic Support System (2007), cited by 3
- K071957: Pinnacle Pelvic Floor Repair Kits (2007), cited by 3
- K053414: Mentor Novasilk Mesh (2005), cited by 3
- K080185: Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP Prolapse Repair System (2008), cited by 3

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