INSULSCAN INSULATION TESTING SYSTEM— 510(k) K991424

Name: FDA 510(k) clearance K991424
Creator: U.S. Food and Drug Administration
Published: 1999-07-22

Substantially Equivalent

Medicor Corp.

FDA 510(k) clearance K991424 for INSULSCAN INSULATION TESTING SYSTEM, Substantially Equivalent on 1999-07-22. Applicant: Medicor Corp.. Device class: 2.

Clearance details

Applicant: Medicor Corp.
Product code: Code HFG
Device class: Class 2
Regulation: 21 CFR 884.4160
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 ↗

Recent devices under product code HFG

view all

K181124 — Acessa ProVu System2018-09-28
K132744 — ACESSA GUIDANCE SYSTEM2014-05-27
K132184 — ACESSA GUIDANCE HANDPIECE2014-04-28
K121858 — THE ABLATION SYSTEM2012-11-05
K101606 — MICROMED PD-8K INSULATION DEFECT DETECTOR2010-10-01

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.