Cleared Special

K110010 - NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM

K110010 is an FDA 510(k) clearance for NEUROPORT CORTICAL MICROELECTRODE ARRAY..., manufactured by Blackrock Microsystems, Inc.. The device is a Class 2 Neurology device with product code GZL cleared through the Special 510(k) pathway after a 37-day FDA review.

K110010 · Blackrock Microsystems, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
37d
Days
Class 2
Risk

K110010 is an FDA 510(k) clearance for the NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Blackrock Microsystems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 9, 2011 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110010

510(k) Number K110010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date February 09, 2011
Days to Decision 37 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 149d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K110010.
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STERILE DISPOSABLES FOR MER
K120098 · Alpha Omega Engineering , Ltd. · Jun 2012
NAVIGATION PROBES
K082404 · We Sense, Ltd. · Feb 2009
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697 · Alpha Omega , Ltd. · Dec 2007
NEUROPORT ELECTRODE
K070272 · Cyberkinetics Neurotechnology Systems, Inc. · Aug 2007
K110010 · NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
Download PDF FDA Summary Blackrock Microsystem…