EROSA DISPOSABLE HYPODERMIC NEEDLE— 510(k) K853980

Name: FDA 510(k) clearance K853980
Creator: U.S. Food and Drug Administration
Published: 1985-10-18

Substantially Equivalent

Rose KG

FDA 510(k) clearance K853980 for EROSA DISPOSABLE HYPODERMIC NEEDLE, Substantially Equivalent on 1985-10-18. Applicant: Rose KG. Device class: 1.

Clearance details

Applicant: Rose KG
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-09-27
Decision date: 1985-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.