# GAS: Suture, Nonabsorbable, Synthetic, Polyester

- Device class: 2; regulation: 21 CFR 878.5000; FDA's rule: 510(k) required
- FDA decisions: 18
- 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)
- 1988: 1
- 1989: 2
- 1990: 5
- 1991: 4
- 1992: 4
- 1994: 1
- 1996: 2
- 2000: 1
- 2010: 1
- 2020: 2

## Most-cited predicates
- K904436: Quickanchor (TM) (1990), cited by 5
- K002261: MR-III (2000), cited by 3
- K091018: Arthrex Biowire (2010), cited by 1
- K902873: Nonabsorbable Dacron Surgical Suture* (1990), cited by 1
- K913101: Peters Cardioflon (TM) Suture (1992), cited by 1
- K904263: Dacron R Surgical Sutures (1990), cited by 1

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