Optilume® High Pressure Urological Balloon Dilation Catheter— 510(k) K250910

Substantially Equivalent

Urotronic, Inc.

FDA 510(k) clearance K250910 for Optilume® High Pressure Urological Balloon Dilation Catheter, Substantially Equivalent on 2025-05-22. Applicant: Urotronic, Inc..

Clearance details

Applicant: Urotronic, Inc.
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2025-03-26
Decision date: 2025-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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.