Cleared Traditional

K070272 - NEUROPORT ELECTRODE

K070272 is an FDA 510(k) clearance for NEUROPORT ELECTRODE, manufactured by Cyberkinetics Neurotechnology Systems, Inc.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K070272 · Cyberkinetics Neurotechnology Systems, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
186d
Days
Class 2
Risk

K070272 is an FDA 510(k) clearance for the NEUROPORT ELECTRODE. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Cyberkinetics Neurotechnology Systems, Inc. (Stoughton, US). The FDA issued a Cleared decision on August 3, 2007 after a review of 186 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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.

FDA 510(k) Submission Details - K070272

510(k) Number K070272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2007
Decision Date August 03, 2007
Days to Decision 186 days
Submission Type Traditional
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
37d slower than avg
Panel avg: 149d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070272.
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
K110010 · Blackrock Microsystems, Inc. · Feb 2011
NAVIGATION PROBES
K082404 · We Sense, Ltd. · Feb 2009
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697 · Alpha Omega , Ltd. · Dec 2007
MICROTARGETING GUIDELINE 4000
K071364 · FHC, Inc. · Jul 2007
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358 · Ad-Tech Medical Instrument Corp · May 2006
NEUROPROBES
K052527 · Alpha Omega Engineering , Ltd. · Apr 2006
K070272 · NEUROPORT ELECTRODE
Download PDF FDA Summary Cyberkinetics Neurote…