GAG
- Product code
- GAG
- Device name
- Stapler, Surgical
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4740
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 6 (direct download)
- 510(k) clearances (all years, FDA)
- 43 (all years; only the last 3 years are listed here)
FDA classification definition
A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253527 | 2026-07-01 | Covidien, LLC | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thi… | |
| K251482 | 2025-07-11 | Lexington Medical, Inc. | AEON Endoscopic Powered Stapler | |
| K243596 | 2025-03-10 | Intuitive Surgical, Inc. | da Vinci SP SureForm 45 Staplers and Reloads (SP1098… | |
| K240881 | 2024-11-01 | Covidien (Part of Medtronic) | Signia Circular Adapter (Standard Length) (SIGCIRST… | |
| K241629 | 2024-07-03 | Ethicon Endo-Surgery, LLC | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon … | |
| K234039 | 2024-05-07 | Lexington Medical, Inc. | AEON Endoscopic Powered Stapler (Short/AEPH060); AEO… | FDA |
| K231934 | 2023-10-27 | Covidien | GIA Stapler with Tri-Staple Technology |
Official FDA classification page: GAG
Classification and pathway per current FDA publications. Data from openFDA (CC0).