SELF ADHERING NAVIGUS GUIDE— 510(k) K001192

Substantially Equivalent

Image-Guided Neurologics, Inc.

FDA 510(k) clearance K001192 for SELF ADHERING NAVIGUS GUIDE, Substantially Equivalent on 2000-06-07. Applicant: Image-Guided Neurologics, Inc..

Clearance details

Applicant: Image-Guided Neurologics, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2000-04-12
Decision date: 2000-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.