Cleared Traditional

K912783 - DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

K912783 is an FDA 510(k) clearance for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, manufactured by Class A Ent.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K912783 · Class A Ent. · Neurology device
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Feb 1992
Decision
226d
Days
Class 2
Risk

K912783 is an FDA 510(k) clearance for the DISPOSABLE MONOPOLAR NEEDLE ELECTRODE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Class A Ent. (Yucca Valley, US). The FDA issued a Cleared decision on February 5, 1992 after a review of 226 days - an extended review 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: 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 - K912783

510(k) Number K912783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1991
Decision Date February 05, 1992
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 149d · This submission: 226d
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 K912783.
GROUND/REFERENCE NEEDLE ELECTRODE
K933793 · Cadwell Laboratories, Inc. · Apr 1994
PROBLOC INSULATED NEEDLES
K926349 · Life-Tech Intl., Inc. · Jul 1993
BIO-DETEK EEG ELECTRODE
K920352 · Bio-Detek, Inc. · Aug 1992
SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
K894911 · Dantec Electronics, Inc. · May 1990
SPECIMEX DC
K900740 · Soredex Medical Systems · May 1990
DISPOSIBLE EEG NEEDLE ELECTRODES
K901280 · Medicotest, Inc. · May 1990
K912783 · DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
Download PDF Class A Ent.