Cleared Traditional

K901499 - NEUROMED OCTRODE MODEL MNR-88 W/98 ADAP...

K901499 is the FDA 510(k) clearance for NEUROMED OCTRODE MODEL MNR-88 W/98 ADAP... by Neuromed, Inc.. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K901499 · Neuromed, Inc. · Neurology device
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Jun 1990
Decision
92d
Days
Class 2
Risk

K901499 is an FDA 510(k) clearance for the NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Neuromed, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on June 29, 1990 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 Neuromed, Inc. devices

Submission Details

510(k) Number K901499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date June 29, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 76
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