Cleared Traditional

K093185 - OWL UNIVERSAL RF SYSTEM URF-3AP (ML)

K093185 is an FDA 510(k) clearance for OWL UNIVERSAL RF SYSTEM URF-3AP (ML), manufactured by Diros Technology, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K093185 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
105d
Days
Class 2
Risk

K093185 is an FDA 510(k) clearance for the OWL UNIVERSAL RF SYSTEM URF-3AP (ML). Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Diros Technology, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on January 22, 2010 after a review of 105 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 - K093185

510(k) Number K093185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2009
Decision Date January 22, 2010
Days to Decision 105 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
44d faster than avg
Panel avg: 149d · This submission: 105d
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 35
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K093185.
MultiGen™ 2 RF Generator System
K170242 · Stryker Corporation · May 2017
ERASE HAND- HELD CONTROLLER
K101592 · Cheng Medical, Corporation · Oct 2011
NT 2000 LESIONING GENERATOR
K111576 · Neuro Therm, Inc. · Sep 2011
COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
K082051 · Cosman Medical, Inc. · Oct 2008
MODIFICATION TO GFX NERVE ABLATION SYSTEM
K081729 · Bioform Medical, Inc. · Aug 2008
STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
K071482 · Synergetics, Inc. · Dec 2007