ReTrace Ureteral Access Sheath— 510(k) K181811

Substantially Equivalent

Coloplast A/S

FDA 510(k) clearance K181811 for ReTrace Ureteral Access Sheath, Substantially Equivalent on 2018-09-07. Applicant: Coloplast A/S.

Clearance details

Applicant: Coloplast A/S
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2018-07-06
Decision date: 2018-09-07
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, 2020-01-01 through 2026-04-23. 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.