# GAQ: Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

- Device class: 2; regulation: 21 CFR 878.4495; FDA's rule: 510(k) required
- FDA decisions: 32
- 510(k) review time 2021–2025: median 477 days (middle half 477–477)
- Recalls: 2 (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: 3
- 2004: 1
- 2005: 1
- 2007: 1
- 2008: 2
- 2014: 2
- 2017: 1
- 2018: 1
- 2020: 1
- 2022: 1

## Most-cited predicates
- K931271: Ethi-Pack* Surgical Stainless Steel Suture (1994), cited by 19
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk (1995), cited by 19
- K030351: Stainless Steel Surgical Suture, Non-Absorbable (2003), cited by 3
- K081060: Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5 (2008), cited by 3
- K170767: Surgical Stainless Steel Suture, Stainless Steel Suture (2017), cited by 3
- K933686: Look Inc. 316L Stainless Steel Surgical Suture (1993), cited by 2
- K013059: Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures) (2001), cited by 2
- K991073: Acier Sutures (1999), cited by 2
- K023411: Steelex Sternum Set (2002), cited by 2
- K023594: Teno Fix (2003), cited by 2

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