In-Ka Ureteral Balloon Dilatation Catheter— 510(k) K201007

Unknown

Coloplast Corp.

FDA 510(k) clearance K201007 for In-Ka Ureteral Balloon Dilatation Catheter, Unknown on 2020-06-11. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2020-04-17
Decision date: 2020-06-11
Decision: Unknown
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.