# GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

- Device class: 2; regulation: 21 CFR 878.5010; FDA's rule: 510(k) required
- FDA decisions: 86
- 510(k) review time 2021–2025: median 201 days (middle half 162–290)
- Recalls: 3 (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)
- 2015: 3
- 2016: 1
- 2017: 3
- 2018: 3
- 2019: 1
- 2020: 2
- 2022: 2
- 2023: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K052373: Quill Nonabsorbable Polypropylene Barbed Suture (2005), cited by 6
- K001625: Pronova Nonabsorbable Suture, Usp (2000), cited by 5
- K041593: Featherlift Extended Length Aptos Thread (2004), cited by 5
- K050947: Modification to: Modified Uss Polypropylene Suture (2005), cited by 3
- K983108: Suture Welding System and Kit (SWK) (1998), cited by 3
- K050548: Contour Midface Opposing Uni-Directional Threads (2005), cited by 3
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (2010), cited by 3
- K050247: Contour Necklift Threads (2005), cited by 2
- K133356: Prolene Polypropylene Nonabsorbable Suture (2013), cited by 2
- K954808: Ussc Polyproplene Suture (1996), cited by 2

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