Tri-staple 2.0 Reloads +3 more— 510(k) K253657
Substantially EquivalentCovidien (Part of Medtronic)
FDA 510(k) clearance K253657 for Tri-staple 2.0 Reloads +3 more, Substantially Equivalent on 2026-04-10. Applicant: Covidien (Part of Medtronic). Device class: 2.
Summary
This clearance covers four families of stapler reloads from Medtronic's Covidien unit: Tri-Staple 2.0 reloads, Endo GIA reloads with Tri-Staple technology, Endo GIA gray articulating reloads, and Signia small diameter reloads. Reloads are the disposable staple cartridges that load into the stapler. Product code GDW covers implantable staples.
Class II, 21 CFR 878.4750. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Covidien filed from North Haven, Connecticut. Review took 141 days (November 20, 2025 to April 10, 2026). Reload filings are routine for stapler makers, since new cartridge sizes and staple configurations each need clearance.
Clearance details
- Device name as filed
- Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
- Applicant
- Covidien (Part of Medtronic)
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
Recent devices under product code GDW
view allMore clearances from Covidien (Part of Medtronic)
view allAdverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.