DeviceClearance

NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010— 510(k) K022100

Substantially Equivalent

Image-Guided Neurologics, Inc.

FDA 510(k) clearance K022100 for NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010, Substantially Equivalent on 2002-09-25. Applicant: Image-Guided Neurologics, Inc.. Device class: 2.

Clearance details

Applicant
Image-Guided Neurologics, Inc.
Product code
Code HAW
Device class
Class 2
Regulation
21 CFR 882.4560
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Melbourne, FL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HAW

product code HAW
Death
52
Injury
1,083
Malfunction
17,300
Total
18,435

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K022100

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022100.

Data sourced from openFDA. This site is unofficial and independent of the FDA.