EPIDURAL ANESTHESIA NEEDLES— 510(k) K854816

Substantially Equivalent

Reganes, Inc.

FDA 510(k) clearance K854816 for EPIDURAL ANESTHESIA NEEDLES, Substantially Equivalent on 1985-12-19. Applicant: Reganes, Inc..

Clearance details

Applicant: Reganes, Inc.
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1985-12-03
Decision date: 1985-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

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Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

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.