GIA Stapler with Tri-Staple Technology— 510(k) K231934

Substantially Equivalent

Covidien

FDA 510(k) clearance K231934 for GIA Stapler with Tri-Staple Technology, Substantially Equivalent on 2023-10-27. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GAG
Advisory panel: General Hospital
Date received: 2023-06-30
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Min Hang District, Shanghai, CN

Download summary PDF View on FDA.gov ↗

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.