ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE— 510(k) K843690

Substantially Equivalent

Popper & Sons, Inc.

FDA 510(k) clearance K843690 for ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE, Substantially Equivalent on 1984-10-25. Applicant: Popper & Sons, Inc..

Clearance details

Applicant: Popper & Sons, Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1984-09-19
Decision date: 1984-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Hyde Park, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GDM

product code GDM

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.