Cleared Traditional

K042375 - SMK, CX, CXE, RCN

K042375 is an FDA 510(k) clearance for SMK, manufactured by Technomed Europe. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K042375 · Technomed Europe · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
55d
Days
Class 2
Risk

K042375 is an FDA 510(k) clearance for the SMK, CX, CXE, RCN. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on October 26, 2004 after a review of 55 days - a notably fast clearance cycle.

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: 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 Technomed Europe devices

FDA 510(k) Submission Details - K042375

510(k) Number K042375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date October 26, 2004
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
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 56
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K042375.
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6
K053082 · Baylis Medical Co., Inc. · Nov 2005
STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE
K043442 · Stryker Instruments · May 2005
COSMAN RF LESION GENERATOR, MODEL RFG-1A
K050084 · Cosman Medical, Inc. · Mar 2005
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