NA NEEDLES— 510(k) K904667

Name: FDA 510(k) clearance K904667
Creator: U.S. Food and Drug Administration
Published: 1990-12-12

Substantially Equivalent

Olympus Corp.

FDA 510(k) clearance K904667 for NA NEEDLES, Substantially Equivalent on 1990-12-12. Applicant: Olympus Corp.. Device class: 1.

Clearance details

Applicant: Olympus Corp.
Product code: Code GDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1990-10-15
Decision date: 1990-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

Download summary PDF View on FDA.gov ↗

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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.