510(k) K192034— HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc

Substantially Equivalent

Pathway, LLC

Clearance details

Applicant: Pathway, LLC
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2019-07-30
Decision date: 2020-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santee, CA, US

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.