TA Stapler and Loading Unit with DST Series Technology— 510(k) K231491

Substantially Equivalent

Covidien

FDA 510(k) clearance K231491 for TA Stapler and Loading Unit with DST Series Technology, Substantially Equivalent on 2023-08-16. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code GAG
Advisory panel: General Hospital
Date received: 2023-05-23
Decision date: 2023-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

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.