REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY— 510(k) K880181

Substantially Equivalent

Reganes, Inc.

FDA 510(k) clearance K880181 for REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY, Substantially Equivalent on 1988-02-11. Applicant: Reganes, Inc..

Clearance details

Applicant: Reganes, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1988-01-15
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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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.