Cleared Traditional

INTRODE INT-8 (K930242) - FDA 510(k) Clearance

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

K930242 · Neuromed, Inc. · Neurology device
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Feb 1994
Decision
379d
Days
Class 2
Risk

K930242 is an FDA 510(k) clearance for the INTRODE INT-8. 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 February 2, 1994 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K930242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1993
Decision Date February 02, 1994
Days to Decision 379 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 148d · This submission: 379d
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 138
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