GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER— 510(k) K132181

Substantially Equivalent

Olympus Surgical Technologies America

FDA 510(k) clearance K132181 for GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER, Substantially Equivalent on 2013-10-21. Applicant: Olympus Surgical Technologies America.

Clearance details

Applicant: Olympus Surgical Technologies America
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2013-07-15
Decision date: 2013-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, 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.