K253527
- 510(k) number
- K253527
- Device name
- Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)
- Applicant
- Covidien, LLC CT · US
- Product code
- GAG — Stapler, Surgical
- Decision date
- 2026-07-01
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253527.pdf
Official FDA record: K253527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.