# GDW: Staple, Implantable

- Device class: 2; regulation: 21 CFR 878.4750; FDA's rule: 510(k) required
- FDA decisions: 284
- 510(k) review time 2021–2025: median 143 days (middle half 86–264)
- Recalls: 105 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 13
- 2018: 7
- 2019: 12
- 2020: 10
- 2021: 9
- 2022: 7
- 2023: 4
- 2024: 2
- 2025: 3
- 2026: 3

## Most-cited predicates
- K111825: Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM) Staplers (2011), cited by 22
- K020779: Proximate and Endopath Linear Cutters and Staplers (2002), cited by 20
- K070887: Endopath Linear Cutters and Staplers and ECHELON60 Endoscopic Linear Cutters and Staplers (and Reloads) (2007), cited by 11
- K983536: Proximate Curved and Straight Intraluminal Staplers (1998), cited by 9
- K062850: Autosuture Circular Eea Surgical Staplers (2006), cited by 8
- K140560: Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon Flex Powered Plus Articulating (2014), cited by 7
- K061156: Endopath Endocutter 60 Endoscopic Linear Cutter, Models EC60, SC60 and LONG60 and Endopath & Proximate Linear Cutters (2006), cited by 7
- K003277: Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33 (2000), cited by 7
- K061095: Auto Sutur Endo Gia Staplers (2006), cited by 7
- K120179: Reach Surgical Staplers (2012), cited by 6

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