# GAG: Stapler, Surgical

- Device class: 2; regulation: 21 CFR 878.4740; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 114 days (middle half 65–141)
- 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)
- 1989: 1
- 1993: 3
- 1994: 2
- 1996: 1
- 1997: 1
- 2022: 1
- 2023: 4
- 2024: 3
- 2025: 2
- 2026: 1

## Most-cited predicates
- K892927: Proximate Linear Cutter Thick Tissue Inst. (1989), cited by 4
- K213633: ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler (2022), cited by 2
- K221629: Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) (2023), cited by 2
- K241629: ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler  (ECH45S); Echelon 3000 45mm Long Stapler  (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler  (ECH60S); Echelon 3000 60mm Long Stapler  (ECH60L) (2024), cited by 2
- K760733: Skin Staple Extractor (1976), cited by 1
- K771177: Surgical Stapling Instru., Auto, Suture (1977), cited by 1

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