KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C— 510(k) K990500

Substantially Equivalent

The Kendal Co.

FDA 510(k) clearance K990500 for KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C, Substantially Equivalent on 1999-09-28. Applicant: The Kendal Co..

Clearance details

Applicant: The Kendal Co.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1999-02-17
Decision date: 1999-09-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Mansfield, MA, US

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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.