K202134

Substantially Equivalent

Well Lead All Silicone Foley Catheter with Temperature Sensor

Applicant: Well Lead Medical Co., Ltd.
Product code: EZL
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-31
Decision date: 2021-04-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Guangzhou, CN

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.