MODIFICATION TO PLEXOLONG SETS— 510(k) K023218

Substantially Equivalent

Pajunk GmbH

FDA 510(k) clearance K023218 for MODIFICATION TO PLEXOLONG SETS, Substantially Equivalent on 2003-03-24. Applicant: Pajunk GmbH.

Clearance details

Applicant: Pajunk GmbH
Product code: Code BSP
Advisory panel: Anesthesiology
Date received: 2002-09-26
Decision date: 2003-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Corvallis, OR, 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.