WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER— 510(k) K133615

Substantially Equivalent

Well Lead Medical Co., Ltd.

FDA 510(k) clearance K133615 for WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER, Substantially Equivalent on 2014-02-24. Applicant: Well Lead Medical Co., Ltd..

Clearance details

Applicant: Well Lead Medical Co., Ltd.
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2013-11-25
Decision date: 2014-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.