DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER— 510(k) K024010

Substantially Equivalent

The Kendall Company Div. of Tyco Healthcare Group

FDA 510(k) clearance K024010 for DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER, Substantially Equivalent on 2003-06-11. Applicant: The Kendall Company Div. of Tyco Healthcare Group.

Clearance details

Applicant: The Kendall Company Div. of Tyco Healthcare Group
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2002-12-04
Decision date: 2003-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, 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.