Cleared Traditional

K082404 - NAVIGATION PROBES

K082404 is an FDA 510(k) clearance for NAVIGATION PROBES, manufactured by We Sense, Ltd.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K082404 · We Sense, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
188d
Days
Class 2
Risk

K082404 is an FDA 510(k) clearance for the NAVIGATION PROBES. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by We Sense, Ltd. (Nazareth, IL). The FDA issued a Cleared decision on February 25, 2009 after a review of 188 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 - K082404

510(k) Number K082404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2008
Decision Date February 25, 2009
Days to Decision 188 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
39d slower than avg
Panel avg: 149d · This submission: 188d
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 K082404.
NEURO OMEGA SYSTEM
K123796 · Alpha Omega Engineering , Ltd. · Apr 2013
STERILE DISPOSABLES FOR MER
K120098 · Alpha Omega Engineering , Ltd. · Jun 2012
NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
K110010 · Blackrock Microsystems, Inc. · Feb 2011
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697 · Alpha Omega , Ltd. · Dec 2007
NEUROPORT ELECTRODE
K070272 · Cyberkinetics Neurotechnology Systems, Inc. · Aug 2007
MICROTARGETING GUIDELINE 4000
K071364 · FHC, Inc. · Jul 2007
K082404 · NAVIGATION PROBES
Download PDF FDA Summary We Sense, Ltd.