CATHETER/HEMOSTATIC/GERIATRIC— 510(k) K780062

Substantially Equivalent

Kendall Research Center

FDA 510(k) clearance K780062 for CATHETER/HEMOSTATIC/GERIATRIC, Substantially Equivalent on 1978-02-14. Applicant: Kendall Research Center.

Clearance details

Applicant: Kendall Research Center
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1978-01-12
Decision date: 1978-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.