Cleared Traditional

K781311 - ELECTRODE, NEEDLE, CFM

K781311 is an FDA 510(k) clearance for ELECTRODE, manufactured by Applied Medical Research. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K781311 · Applied Medical Research · Neurology device
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Aug 1978
Decision
21d
Days
Class 2
Risk

K781311 is an FDA 510(k) clearance for the ELECTRODE, NEEDLE, CFM. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Applied Medical Research (Mchenry, US). The FDA issued a Cleared decision on August 21, 1978 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Applied Medical Research devices

FDA 510(k) Submission Details - K781311

510(k) Number K781311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1978
Decision Date August 21, 1978
Days to Decision 21 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 148d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

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.