K221003

Substantially Equivalent

Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA

Applicant: Covidien
Product code: GDW
Advisory panel: General, Plastic Surgery
Date received: 2022-04-05
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Haven, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.