DeviceClearance

K242845

Unknown

EGIS Biliary Double Bare Stent (BDB080405)

Applicant
S&G Biotech, Inc.
Product code
FGE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Yongin-Si, KR
Download summary PDF View on FDA.gov ↗

Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

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.