GDW
- Product code
- GDW
- Device name
- Staple, Implantable
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4750
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 283 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260196 | 2026-05-11 | Ethicon Endo-Surgery, LLC | ETHICON Circular Stapler (CDH21mm); ETHICON Circul… | |
| K253657 | 2026-04-10 | Covidien (Part of Medtronic) | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-… | |
| K252739 | 2025-12-17 | Ethicon Endo-Surgery, LLC | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHIC… | FDA |
| K250835 | 2025-05-14 | Ethicon Endo-Surgery, LLC | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON… | |
| K243276 | 2025-02-25 | Ethicon Endo-Surgery, LLC | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELO… | |
| K241630 | 2024-10-28 | Ethicon Endo-Surgery, LLC | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON… | |
| K242679 | 2024-10-04 | Fengh Medical Co., Ltd. | Disposable Powered Articulating Endoscopic Linear Cu… | FDA |
Official FDA classification page: GDW
Classification and pathway per current FDA publications. Data from openFDA (CC0).