E-Z-EM VACUUM ASPIRATION SYRINGE— 510(k) K895012

Name: FDA 510(k) clearance K895012
Creator: U.S. Food and Drug Administration
Published: 1989-12-27

Substantially Equivalent

E-Z-Em, Inc.

FDA 510(k) clearance K895012 for E-Z-EM VACUUM ASPIRATION SYRINGE, Substantially Equivalent on 1989-12-27. Applicant: E-Z-Em, Inc.. Device class: 1.

Clearance details

Applicant: E-Z-Em, Inc.
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1989-08-08
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westbury, NY, 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.