Cleared Traditional

K915741 - DISPOSABLE MONOPLAR MEDDLE ELECTRODES

K915741 is an FDA 510(k) clearance for DISPOSABLE MONOPLAR MEDDLE ELECTRODES, manufactured by Dantec Medical, Inc.. The device is a Class 1 Neurology device with product code GXE cleared through the Traditional 510(k) pathway after a 354-day FDA review.

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

FDA 510(k) Submission Details - K915741

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.

GXE Device Classification - Class 1, General Controls

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.