Cleared Traditional

K143241 - MDT Navigable Brain Biopsy Cannula

K143241 is the FDA 510(k) clearance for MDT Navigable Brain Biopsy Cannula by Izi Medical Products, LLC. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K143241 · Izi Medical Products, LLC · Neurology device
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Apr 2015
Decision
152d
Days
Class 2
Risk

K143241 is an FDA 510(k) clearance for the MDT Navigable Brain Biopsy Cannula. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Izi Medical Products, LLC (Owings Mills, US). The FDA issued a Cleared decision on April 13, 2015 after a review of 152 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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 Izi Medical Products, LLC devices

Submission Details

510(k) Number K143241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2014
Decision Date April 13, 2015
Days to Decision 152 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 148d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 226
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K143241.
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