Cleared Traditional

K050084 - COSMAN RF LESION GENERATOR, MODEL RFG-1A

Also marketed or referenced as:
COSMAN TEW TRIGEMINAL ELECTRODE KIT COSMAN TIC TRIGEMINAL ELECTRODE KIT

K050084 is an FDA 510(k) clearance for COSMAN RF LESION GENERATOR, manufactured by Cosman Medical, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K050084 · Cosman Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
63d
Days
Class 2
Risk

K050084 is an FDA 510(k) clearance for the COSMAN RF LESION GENERATOR, MODEL RFG-1A. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Cosman Medical, Inc. (Burlington, US). The FDA issued a Cleared decision on March 17, 2005 after a review of 63 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.

FDA 510(k) Submission Details - K050084

510(k) Number K050084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2005
Decision Date March 17, 2005
Days to Decision 63 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
86d faster than avg
Panel avg: 149d · This submission: 63d
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 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K050084.
LESIONPOINT RF CANNULA
K053415 · Cosman Medical, Inc. · Apr 2006
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
SMK, CX, CXE, RCN
K042375 · Technomed Europe · Oct 2004
RF INTRODUCTION CANNULA
K041021 · Epimed International, Inc. · Sep 2004
STRYKER RF ELECTRODES AND CANNULAE
K032406 · Stryker Instruments · Apr 2004
K050084 · COSMAN RF LESION GENERATOR, MODEL RFG-1A
Download PDF FDA Summary Cosman Medical, Inc.