Cleared Traditional

RE-USABLE MONOPOLAR NEEDLE (K953886) - FDA 510(k) Clearance

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

K953886 · Chalgren Enterprises, Inc. · Neurology device
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Oct 1995
Decision
75d
Days
Class 2
Risk

K953886 is an FDA 510(k) clearance for the RE-USABLE MONOPOLAR NEEDLE. Classified as Electrode, Needle, Diagnostic Electromyograph (product code IKT), Class II - Special Controls.

Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on October 31, 1995 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1385 - 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 Chalgren Enterprises, Inc. devices

Submission Details

510(k) Number K953886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1995
Decision Date October 31, 1995
Days to Decision 75 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
73d faster than avg
Panel avg: 148d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKT Electrode, Needle, Diagnostic Electromyograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1385
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.