Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray Articulating Reloads; Signia Small Diameter Reloads
Device Facts
| Record ID | K253657 |
|---|---|
| Device Name | 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 | GDW · General, Plastic Surgery |
| Decision Date | Apr 10, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
