DeviceClearance

K003949

Substantially Equivalent

TACKER, MODEL R65-933

Applicant
A & A Medical, Inc.
Product code
OCW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alpharetta, GA, 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.