Cleared Traditional

K993622 - NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY

K993622 is an FDA 510(k) clearance for NEUROTREK PHYSIOLOGICAL NAVIGATION SYST..., manufactured by Alpha Omega , Ltd.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K993622 · Alpha Omega , Ltd. · Neurology device
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Jan 2000
Decision
90d
Days
Class 2
Risk

K993622 is an FDA 510(k) clearance for the NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Alpha Omega , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on January 24, 2000 after a review of 90 days - within the typical 510(k) review window.

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 Alpha Omega , Ltd. devices

FDA 510(k) Submission Details - K993622

510(k) Number K993622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1999
Decision Date January 24, 2000
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 34
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K993622.
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
MICROTARGETING ELECTRODE
K991522 · FHC, Inc. · Aug 2000
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · Ad-Tech Medical Instrument Corp · Nov 1999
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
K991077 · Microrecording Systems Consultants, LLC · Jun 1999
NEUROMAP
K981820 · Radionics, Inc. · Nov 1998