Cleared Special

NEUROWAVE MICRO-INFUSION SYSTEM (K062508) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K062508 · Ekos Corp. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2006
Decision
99d
Days
Class 2
Risk

K062508 is an FDA 510(k) clearance for the NEUROWAVE MICRO-INFUSION SYSTEM. Classified as Ultrasound, Infusion, System (product code NUI), Class II - Special Controls.

Submitted by Ekos Corp. (Bothell, US). The FDA issued a Cleared decision on December 5, 2006 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.1200 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ekos Corp. devices

Submission Details

510(k) Number K062508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received August 28, 2006
Decision Date December 05, 2006
Days to Decision 99 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 148d · This submission: 99d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NUI Ultrasound, Infusion, System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Regional Infusion Of Contrast Materials Into Selected Vessels In The Neuro-vasculature. The Device May Be Used For Controlled, Regional Infusion Into Selected Vessels And Is Not Intended For Use In The Coronary Vasculature.
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.