Cleared Traditional

K110410 - MS-120BK ELECTRIC STIMULATOR (EXTENSION...

K110410 is an FDA 510(k) clearance for MS-120BK ELECTRIC STIMULATOR (EXTENSION..., manufactured by Nihon Kohden Corp.. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K110410 · Nihon Kohden Corp. · Neurology device
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Aug 2011
Decision
171d
Days
Class 2
Risk

K110410 is an FDA 510(k) clearance for the MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT). Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on August 4, 2011 after a review of 171 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 Nihon Kohden Corp. devices

FDA 510(k) Submission Details - K110410

510(k) Number K110410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2011
Decision Date August 04, 2011
Days to Decision 171 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 148d · This submission: 171d
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 18
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K110410.
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PMT SUBDURAL CORTICAL ELECTRODES
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NICOLET CORTICAL STIMULATOR
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