ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE— 510(k) K901811

Substantially Equivalent

Neuro Technology

FDA 510(k) clearance K901811 for ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE, Substantially Equivalent on 1991-05-28. Applicant: Neuro Technology.

Clearance details

Applicant: Neuro Technology
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 1990-04-20
Decision date: 1991-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, 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.