DeviceClearance

K012977

Substantially Equivalent

VARICES INJECTION NEEDLE

Applicant
Endo-Therapeutics, Inc.
Product code
FBK
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Safety Harbor, FL, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK
Other
1
Total
1

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.