DeviceClearance

K232126

Substantially Equivalent

EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil

Applicant
Covidien
Product code
GAG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
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, 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.