OLYMPUS NA-10J-1 ASPIRATION NEEDLE— 510(k) K970563

Name: FDA 510(k) clearance K970563
Creator: U.S. Food and Drug Administration
Published: 1997-04-11

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K970563 for OLYMPUS NA-10J-1 ASPIRATION NEEDLE, Substantially Equivalent on 1997-04-11. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FCG
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1997-02-13
Decision date: 1997-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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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.