PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS— 510(k) K061009

Substantially Equivalent

Onset Medical Corporation

FDA 510(k) clearance K061009 for PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS, Substantially Equivalent on 2006-05-02. Applicant: Onset Medical Corporation.

Clearance details

Applicant: Onset Medical Corporation
Product code: Code EZN
Advisory panel: Gastroenterology, Urology
Date received: 2006-04-12
Decision date: 2006-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Mission Viejo, CA, 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.