DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE— 510(k) K941206

Substantially Equivalent

New Eder Corp.

FDA 510(k) clearance K941206 for DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE, Substantially Equivalent on 1995-07-25. Applicant: New Eder Corp..

Clearance details

Applicant: New Eder Corp.
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1994-03-14
Decision date: 1995-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Groove Village, IL, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.