WELL LEAD SILICONE AND LATEX FOLEY CATHETERS— 510(k) K082815

Substantially Equivalent

Well Lead Medical Instruments

FDA 510(k) clearance K082815 for WELL LEAD SILICONE AND LATEX FOLEY CATHETERS, Substantially Equivalent on 2008-10-08. Applicant: Well Lead Medical Instruments.

Clearance details

Applicant: Well Lead Medical Instruments
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2008-09-25
Decision date: 2008-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou City, 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.