Cleared Special

K113533 - NEURO CHECK DEVICE WITH IO-FLEX WIRE (FDA 510(k) Clearance)

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

K113533 · Baxano, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
133d
Days
Class 2
Risk

K113533 is an FDA 510(k) clearance for the NEURO CHECK DEVICE WITH IO-FLEX WIRE. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Baxano, Inc. (San Jose, US). The FDA issued a Cleared decision on April 11, 2012 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - 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 Baxano, Inc. devices

Submission Details

510(k) Number K113533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date April 11, 2012
Days to Decision 133 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
15d faster than avg
Panel avg: 148d · This submission: 133d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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.

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