# GAR: Suture, Nonabsorbable, Synthetic, Polyamide

- Device class: 2; regulation: 21 CFR 878.5020; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 202 days (middle half 165–330)
- Recalls: 5 (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)
- 2008: 1
- 2013: 1
- 2015: 1
- 2016: 1
- 2017: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2026: 1

## Most-cited predicates
- K981582: Surgilon, Dermalon, & Ophthalon (1998), cited by 5
- K001173: Nylon, Nonabsorbable Surgical Sutures Usp (2000), cited by 4
- K161633: Rexlon, Rexsil (2017), cited by 4
- K003000: Grams Nylon Nonabsorbable Suture (2000), cited by 3
- K993998: NYLON (2000), cited by 3
- K930586: Dermalon,Surgilon,Ophthalon,& Ophthalmic Nylon Sut (1993), cited by 2
- K151165: Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (2016), cited by 2
- K990090: Dafilon Nonabsorbable Polyamide Surgical Suture (1999), cited by 2
- K220980: Tissue Approximation System (TAS) (2023), cited by 1
- K123034: Vital Sutures Suturex Cirugia Peruana Sutumed (2013), cited by 1

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