DeviceClearance

K213633

Substantially Equivalent

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

Applicant
Ethicon Endo-Surgery, LLC
Product code
GAG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guaynabo, PR, 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, 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.