DeviceClearance

K850954

Substantially Equivalent

URETERAL DILATOR & URETERAL STONE DISLODGER

Applicant
American Edwards Laboratories
Product code
FFL
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Ana, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FFL

product code FFL
Death
2
Injury
270
Malfunction
2,711
Other
2
Total
2,985

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.