DeviceClearance

K132065

Substantially Equivalent

INJECTION NEEDLE

Applicant
Endochoice, Inc.
Product code
FBK
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 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.