Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12)— 510(k) K242173

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K242173 for Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12), Substantially Equivalent on 2024-11-12. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2024-07-24
Decision date: 2024-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
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.