Ureteral Dilators and Percutaneous Nephrostomy Dilators— 510(k) K170531

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K170531 for Ureteral Dilators and Percutaneous Nephrostomy Dilators, Substantially Equivalent on 2017-08-17. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2017-02-22
Decision date: 2017-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZN

product code EZN

Death: 3
Injury: 127
Total: 130

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.