Cleared Traditional

K011387 - NEUROTHERM, MODEL JK4

K011387 is an FDA 510(k) clearance for NEUROTHERM, manufactured by Eurolink, LLC. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K011387 · Eurolink, LLC · Neurology device
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Sep 2001
Decision
122d
Days
Class 2
Risk

K011387 is an FDA 510(k) clearance for the NEUROTHERM, MODEL JK4. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Eurolink, LLC (Lynnfield, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 122 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 Eurolink, LLC devices

FDA 510(k) Submission Details - K011387

510(k) Number K011387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date September 06, 2001
Days to Decision 122 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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXI Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K011387.
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STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · Smith & Nephew, Inc. · Mar 2004
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY
K002389 · Baylis Medical Co., Inc. · Oct 2000
ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
K001588 · Arthrocare Corp. · Aug 2000
NEUROTHERM RF CANNULA
K994344 · Rocket Medical Plc · Mar 2000