INSULSCAN INSULATION TESTING SYSTEM— 510(k) K991424

Substantially Equivalent

Medicor Corp.

FDA 510(k) clearance K991424 for INSULSCAN INSULATION TESTING SYSTEM, Substantially Equivalent on 1999-07-22. Applicant: Medicor Corp..

Clearance details

Applicant: Medicor Corp.
Product code: Code HFG
Advisory panel: Obstetrics/Gynecology
Date received: 1999-04-23
Decision date: 1999-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HFG

product code HFG

Death: 3
Injury: 121
Total: 124

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.