DeviceClearance

K181811

Substantially Equivalent

ReTrace Ureteral Access Sheath

Applicant
Coloplast A/S
Product code
FED
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Plymouth, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED
Death
10
Total
10

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.