Cleared Traditional

K040639 - ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

K040639 is an FDA 510(k) clearance for ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, manufactured by Isurgical. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K040639 · Isurgical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
72d
Days
Class 2
Risk

K040639 is an FDA 510(k) clearance for the ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Isurgical (Mundelein, US). The FDA issued a Cleared decision on May 21, 2004 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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.

FDA 510(k) Submission Details - K040639

510(k) Number K040639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date May 21, 2004
Days to Decision 72 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
77d faster than avg
Panel avg: 149d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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 - GXZ Electrode, Needle

All 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K040639.
XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
K052111 · Excel Tech. , Ltd. · Aug 2005
DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
K050325 · Technomed Europe · May 2005
AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
K050194 · Axon Systems, Inc. · Apr 2005
LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
K023472 · Class A Enterprises, Inc. · Mar 2003
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
K022914 · Rhythmlink International, LLC · Dec 2002
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
K020910 · The Electrode Store, Inc. · Jul 2002
K040639 · ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
Download PDF FDA Summary Isurgical