MEDIZIV EPIDURAL SYSTEMS— 510(k) K894725

Name: FDA 510(k) clearance K894725
Creator: U.S. Food and Drug Administration
Published: 1989-10-13

Substantially Equivalent

Mediziv Medical Devices, Ltd.

FDA 510(k) clearance K894725 for MEDIZIV EPIDURAL SYSTEMS, Substantially Equivalent on 1989-10-13. Applicant: Mediziv Medical Devices, Ltd.. Device class: 2.

Clearance details

Applicant: Mediziv Medical Devices, Ltd.
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 1989-07-25
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.