Cleared Traditional

K110410 - MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) (FDA 510(k) Clearance)

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

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

Submission Details

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.

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
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