K082681

Substantially Equivalent

VACORA VACUUM ASSISTED BIOPSY SYSTEM

Applicant
C.R. Bard, Inc.
Product code
KNW
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Tempe, AZ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW
Death
9
Injury
965
Malfunction
10,444
Other
3
Total
11,421

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.