Cleared Traditional

K041021 - RF INTRODUCTION CANNULA

K041021 is the FDA 510(k) clearance for RF INTRODUCTION CANNULA by Epimed International, Inc.. It is a Class 2 Neurology device (product code GXI) cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K041021 · Epimed International, Inc. · Neurology device
Download Printable Device Report (PDF)
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Sep 2004
Decision
149d
Days
Class 2
Risk

K041021 is an FDA 510(k) clearance for the RF INTRODUCTION CANNULA. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - 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. Standard predicate reliance. 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 Epimed International, Inc. devices

Submission Details

510(k) Number K041021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2004
Decision Date September 16, 2004
Days to Decision 149 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
1d slower than avg
Panel avg: 148d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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.

Regulatory Peers - GXI Probe, Radiofrequency Lesion

All 31
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K041021.
SMITH & NEPHEW RF CANNULAE
K063467 · Smith & Nephew, Inc. · Nov 2006
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
K060397 · PAJUNK GmbH Medizintechnologie · Aug 2006
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · Stryker Instruments · May 2005
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000