Cleared Traditional

SD LTM STIM Cortical Stimulator (K180761) - FDA 510(k) Clearance

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

K180761 · Micromed S.P.A. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
87d
Days
Class 2
Risk

K180761 is an FDA 510(k) clearance for the SD LTM STIM Cortical Stimulator. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Micromed S.P.A. (Mogliano Veneto, IT). The FDA issued a Cleared decision on June 18, 2018 after a review of 87 days - a notably fast clearance 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: 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 Micromed S.P.A. devices

Submission Details

510(k) Number K180761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2018
Decision Date June 18, 2018
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 Consultant

Spectramedex, LLC
John Ziobro

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GYC Electrode, Cortical

All 10
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K180761.
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
NeuroOne Cortical Electrode
K192764 · Neuroone, Inc. · Nov 2019
AirRay Subdural Cortical Electrodes
K183437 · Cortec GmbH · Mar 2019
g.Estim PRO
K173684 · G.Tec Medical Engineering GmbH · May 2018