Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) +1 more— 510(k) K253527
Substantially EquivalentCovidien, LLC
FDA 510(k) clearance K253527 for Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT) +1 more, Substantially Equivalent on 2026-07-01. Applicant: Covidien, LLC. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code
- Code GAG
- Device class
- Class 2
- Regulation
- 21 CFR 878.4740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Haven, CT, US
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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, 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.