Cleared Traditional

K000195 - CRANIAL DRILL (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000195 · Image-Guided Neurologics, Inc. · Neurology device
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Apr 2000
Decision
90d
Days
Class 2
Risk

K000195 is an FDA 510(k) clearance for the CRANIAL DRILL. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Melbourne, US). The FDA issued a Cleared decision on April 20, 2000 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Image-Guided Neurologics, Inc. devices

Submission Details

510(k) Number K000195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date April 20, 2000
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.