Cleared Traditional

K242618 - Layer 7-T

K242618 is an FDA 510(k) clearance for Layer 7-T, manufactured by Precision Neuroscience, Corp.. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K242618 · Precision Neuroscience, Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
208d
Days
Class 2
Risk

K242618 is an FDA 510(k) clearance for the Layer 7-T. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Precision Neuroscience, Corp. (Mountain View, US). The FDA issued a Cleared decision on March 30, 2025 after a review of 208 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 Precision Neuroscience, Corp. devices

FDA 510(k) Submission Details - K242618

510(k) Number K242618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2024
Decision Date March 30, 2025
Days to Decision 208 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
60d slower than avg
Panel avg: 148d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K242618.
Atlas Stim Headbox (NK) (31-0601-0077)
K250094 · Neuralynx, Inc. · Apr 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
Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
K191346 · Blackrock Microsystems · Feb 2020
Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
K191186 · Ad-Tech Medical Instrument Corporation · Jan 2020