3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS— 510(k) K022287

Substantially Equivalent

3t Medical Systems, LLC

FDA 510(k) clearance K022287 for 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS, Substantially Equivalent on 2002-09-23. Applicant: 3t Medical Systems, LLC.

Clearance details

Applicant: 3t Medical Systems, LLC
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2002-07-15
Decision date: 2002-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conifer, CO, US

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.