# OTN: Mesh, Surgical, 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: 66
- 510(k) review time 2021–2025: median 70 days (middle half 35–89)
- 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)
- 2012: 1
- 2013: 5
- 2014: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 3
- 2022: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- K011251: Sparc Sling System (2001), cited by 13
- K974098: Pubouurethral Sling (1998), cited by 12
- K023516: Monarc Sling System (2002), cited by 10
- K021263: Modification to Sparc Sling System (2002), cited by 10
- K013355: Sparc Sling System (2001), cited by 10
- K020663: Modification to Sparc Sling System (2002), cited by 7
- K020007: Safyre Sling System (2002), cited by 6
- K020110: Modification to Trelex Mesh Surgical Mesh (2002), cited by 6
- K033568: Gynecare TVT Obturator System (2003), cited by 6
- K012628: Gynecare Tension-Free Vaginal Tape System (2001), cited by 4

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