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

Name: FDA 510(k) clearance K082815
Creator: U.S. Food and Drug Administration
Published: 2008-10-08

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. Device class: 2.

Clearance details

Applicant: Well Lead Medical Instruments
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
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 ↗

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K073383 — WELL LEAD REINFORCED ENDOTRACHEAL TUBE2008-07-10
K042683 — WELL LEAD ENDOTRACHEAL TUBE2005-02-18
K042684 — WELL LEAD TRACHEOSTOMY TUBE2005-02-17

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.