Cleared Traditional

K934779 - AGRAM SPYRAL ELECTRODE

K934779 is an FDA 510(k) clearance for AGRAM SPYRAL ELECTRODE, manufactured by Agram Export-Import Co.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 524-day FDA review.

K934779 · Agram Export-Import Co. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
524d
Days
Class 2
Risk

K934779 is an FDA 510(k) clearance for the AGRAM SPYRAL ELECTRODE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Agram Export-Import Co. (Glen Rock, US). The FDA issued a Cleared decision on March 14, 1995 after a review of 524 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Agram Export-Import Co. devices

FDA 510(k) Submission Details - K934779

510(k) Number K934779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1993
Decision Date March 14, 1995
Days to Decision 524 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
376d slower than avg
Panel avg: 148d · This submission: 524d
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 39
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K934779.
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc. · Jan 1999
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · Jack'S Electrodes · Jan 1998
DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
K950314 · Dantec Medical, Inc. · Mar 1996
EEG NEEDLE ELECTRODE
K933796 · Cadwell Laboratories, Inc. · Dec 1994
CONCENTRIC EMG NEEDLE ELECTRODE
K933795 · Cadwell Laboratories, Inc. · Apr 1994
MONOPOLAR EMG NEEDLE ELECTRODE
K933806 · Cadwell Laboratories, Inc. · Apr 1994