Cleared Traditional

K915741 - DISPOSABLE MONOPLAR MEDDLE ELECTRODES (FDA 510(k) Clearance)

Class I Neurology device.

K915741 · Dantec Medical, Inc. · Neurology device
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Dec 1992
Decision
354d
Days
Class 1
Risk

K915741 is an FDA 510(k) clearance for the DISPOSABLE MONOPLAR MEDDLE ELECTRODES. Classified as Leukotome (product code GXE), Class I - General Controls.

Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on December 8, 1992 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4600 - 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 Dantec Medical, Inc. devices

Submission Details

510(k) Number K915741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date December 08, 1992
Days to Decision 354 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
206d slower than avg
Panel avg: 148d · This submission: 354d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GXE Leukotome
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4600
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.