Cleared Traditional

K970418 - PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)

K970418 is an FDA 510(k) clearance for PMT ACCESSORY DEPTHALON ELECTRODE ANCHO..., manufactured by Pmt Corp.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K970418 · Pmt Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
84d
Days
Class 2
Risk

K970418 is an FDA 510(k) clearance for the PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX). Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on April 29, 1997 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pmt Corp. devices

FDA 510(k) Submission Details - K970418

510(k) Number K970418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1997
Decision Date April 29, 1997
Days to Decision 84 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
64d faster than avg
Panel avg: 148d · This submission: 84d
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 44
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K970418.
AD-TECH'S SPINAL ELECTRODE
K973454 · Ad-Tech Medical Instrument Corp · Jun 1998
GUIDELINE SYSTEM
K970943 · Axon Instruments, Inc. · Aug 1997
AD-TECH'S DEPTH ELECTRODE
K964644 · Ad-Tech Medical Instrument Corp · May 1997
CUEVA CRANIAL NERVE ELECTRODE
K944061 · Ad-Tech Medical Instrument Corp · Jan 1995
AD-TECH'S DEPTH ELECTRODE
K891920 · Ad-Tech Medical Instrument Corp · Jul 1989
WYLER SPHENOIDAL ELECTRODE
K861031 · Ad-Tech Medical Instrument Corp · Aug 1986