EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT— 510(k) K964783

Substantially Equivalent

Alexander Medical, Inc.

FDA 510(k) clearance K964783 for EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT, Substantially Equivalent on 1997-02-12. Applicant: Alexander Medical, Inc..

Clearance details

Applicant: Alexander Medical, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1996-11-27
Decision date: 1997-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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.