Cleared Traditional

K973454 - AD-TECH'S SPINAL ELECTRODE

K973454 is an FDA 510(k) clearance for AD-TECH'S SPINAL ELECTRODE, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K973454 · Ad-Tech Medical Instrument Corp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
272d
Days
Class 2
Risk

K973454 is an FDA 510(k) clearance for the AD-TECH'S SPINAL ELECTRODE. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on June 10, 1998 after a review of 272 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 Ad-Tech Medical Instrument Corp devices

FDA 510(k) Submission Details - K973454

510(k) Number K973454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1997
Decision Date June 10, 1998
Days to Decision 272 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
124d slower than avg
Panel avg: 148d · This submission: 272d
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 24
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K973454.
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
K033730 · Pmt Corp. · Aug 2004
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · Ad-Tech Medical Instrument Corp · Nov 1999
NEUROMAP
K981820 · Radionics, Inc. · Nov 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