Cleared Traditional

K970943 - GUIDELINE SYSTEM

K970943 is an FDA 510(k) clearance for GUIDELINE SYSTEM, manufactured by Axon Instruments, Inc.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K970943 · Axon Instruments, Inc. · Neurology device
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Aug 1997
Decision
157d
Days
Class 2
Risk

K970943 is an FDA 510(k) clearance for the GUIDELINE SYSTEM. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Axon Instruments, Inc. (Foster City, US). The FDA issued a Cleared decision on August 18, 1997 after a review of 157 days - an extended review 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: 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 Axon Instruments, Inc. devices

FDA 510(k) Submission Details - K970943

510(k) Number K970943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1997
Decision Date August 18, 1997
Days to Decision 157 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
9d slower than avg
Panel avg: 148d · This submission: 157d
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 30
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K970943.
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · Ad-Tech Medical Instrument Corp · Nov 1999
NEUROMAP
K981820 · Radionics, Inc. · Nov 1998
AD-TECH'S SPINAL ELECTRODE
K973454 · Ad-Tech Medical Instrument Corp · Jun 1998
AD-TECH'S DEPTH ELECTRODE
K964644 · Ad-Tech Medical Instrument Corp · May 1997
PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
K970418 · Pmt Corp. · Apr 1997
CUEVA CRANIAL NERVE ELECTRODE
K944061 · Ad-Tech Medical Instrument Corp · Jan 1995