Cleared Traditional

K850342 - WYLER SUBDURAL STRIP ELECTRODE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K850342 · Ad-Tech Medical Instrument Corp · Neurology device
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Jul 1985
Decision
183d
Days
Class 2
Risk

K850342 is an FDA 510(k) clearance for the WYLER SUBDURAL STRIP ELECTRODE. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 183 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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

Submission Details

510(k) Number K850342 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 28, 1985
Decision Date July 30, 1985
Days to Decision 183 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 148d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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 - GYC Electrode, Cortical

All 31
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K850342.
Atlas Stim Headbox (NK) (31-0601-0077)
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Layer 7-T
K242618 · Precision Neuroscience, Corp. · Mar 2025
WISE Cortical Strip (WCS)
K221123 · Wise S.R.L. · Nov 2022
Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
K211954 · Spes Medica Srl · Nov 2022
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931 · Dixi Medical · Oct 2021