DeviceClearance

K152069

Substantially Equivalent

Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter

Applicant
Navilyst Medical, Inc.
Product code
FGE
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlborough, MA, US
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.