DeviceClearance

K082044

Substantially Equivalent

ACE STAPLER, MODEL F0031

Applicant
Barosense, Inc.
Product code
OCW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redwood City, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW
Death
6
Injury
443
Malfunction
1,023
Other
2
Total
1,474

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.