DISPOSABLE ASPIRATION NEEDLE NA-200H— 510(k) K023272

Substantially Equivalent

The Olympus Optical Co.

FDA 510(k) clearance K023272 for DISPOSABLE ASPIRATION NEEDLE NA-200H, Substantially Equivalent on 2002-12-23. Applicant: The Olympus Optical Co..

Clearance details

Applicant: The Olympus Optical Co.
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2002-10-01
Decision date: 2002-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.