Cleared Traditional

K082051 - COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4

K082051 is an FDA 510(k) clearance for COSMAN G4 RADIOFREQUENCY GENERATOR, manufactured by Cosman Medical, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K082051 · Cosman Medical, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
90d
Days
Class 2
Risk

K082051 is an FDA 510(k) clearance for the COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Cosman Medical, Inc. (Burlington, US). The FDA issued a Cleared decision on October 16, 2008 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - 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.

FDA 510(k) Submission Details - K082051

510(k) Number K082051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2008
Decision Date October 16, 2008
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXD Device Classification - Class 2, Special Controls

Product Code GXD Generator, Lesion, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4400
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 - GXD Generator, Lesion, Radiofrequency

All 36
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K082051.
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K071482 · Synergetics, Inc. · Dec 2007
GFX NERVE ABLATION SYSTEM
K063753 · Aci, Inc. · Jun 2007
K082051 · COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
Download PDF FDA Summary Cosman Medical, Inc.