K253657
- 510(k) number
- 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) CT · US
- Product code
- GDW — Staple, Implantable
- Decision date
- 2026-04-10
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253657.pdf
Official FDA record: K253657
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.