Cleared Traditional

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP) (K863135) - FDA 510(k) Clearance

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

K863135 · Neurotechnics, Inc. · Neurology device
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Sep 1987
Decision
385d
Days
Class 2
Risk

K863135 is an FDA 510(k) clearance for the LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP). Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Neurotechnics, Inc. (Annapolis, US). The FDA issued a Cleared decision on September 4, 1987 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - 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 Neurotechnics, Inc. devices

Submission Details

510(k) Number K863135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date September 04, 1987
Days to Decision 385 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 148d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
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.