510(k) K253527— Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)

Substantially Equivalent

Covidien, LLC

Clearance details

Applicant: Covidien, LLC
Product code: Code GAG
Advisory panel: General Hospital
Date received: 2025-11-13
Decision date: 2026-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Adverse events under product code GAG

product code GAG

Death: 23
Injury: 394
Malfunction: 2,304
Other: 6
Total: 2,727

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.