Well Lead All Silicone Foley Catheter with Temperature Sensor— 510(k) K202134

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K202134 for Well Lead All Silicone Foley Catheter with Temperature Sensor, Substantially Equivalent on 2021-04-08. Applicant: Well Lead Medical Co., Ltd..

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.