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)
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.

View all We Sense, Ltd. devices

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
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 148d · 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 32
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K082404.
microTargeting Guideline 4000 5.0 System
K183123 · FHC, Inc. · Dec 2018
Anchor Bolt (as an accessory to Depth Electrodes)
K181544 · Ad-Tech Medical Instrument Corporation · Aug 2018
NeuroNav System, NeuroSmart System
K172042 · Alpha Omega Engineering , Ltd. · Feb 2018
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358 · Ad-Tech Medical Instrument Corp · May 2006
MACRO-MICRO DEPTH ELECTRODE
K041604 · Ad-Tech Medical Instrument Corp · Aug 2004
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004