Cleared Traditional

K071364 - MICROTARGETING GUIDELINE 4000

K071364 is an FDA 510(k) clearance for MICROTARGETING GUIDELINE 4000, manufactured by FHC, Inc.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K071364 · FHC, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
70d
Days
Class 2
Risk

K071364 is an FDA 510(k) clearance for the MICROTARGETING GUIDELINE 4000. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by FHC, Inc. (Bowdoin, US). The FDA issued a Cleared decision on July 25, 2007 after a review of 70 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all FHC, Inc. devices

FDA 510(k) Submission Details - K071364

510(k) Number K071364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2007
Decision Date July 25, 2007
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 149d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DANIEL W LEHTONEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZL Electrode, Depth

All 54
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K071364.
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
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
NEURODRIVE SYSTEM
K051830 · Alpha Omega , Ltd. · Sep 2005