Cleared Special

K021869 - OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP

K021869 is an FDA 510(k) clearance for OWL RADIOFREQUENCY SYSTEM, manufactured by Diros Technology, Inc.. The device is a Class 2 Neurology device with product code GXD cleared through the Special 510(k) pathway after a 25-day FDA review.

K021869 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
25d
Days
Class 2
Risk

K021869 is an FDA 510(k) clearance for the OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP. Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Diros Technology, Inc. (Charleston, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4400 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K021869

510(k) Number K021869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2002
Decision Date July 01, 2002
Days to Decision 25 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 149d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K021869.
NT-1000
K052878 · Neuro Therm, Inc. · Jan 2006
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
K040565 · Physician Industries, Inc. · Jul 2004
STRYKER INTERVENTIONAL PAIN RF GENERATOR
K032601 · Valley Forge Scientific Corp. · Apr 2004
BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)
K020354 · Baylis Medical Co., Inc. · May 2002
OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
K010202 · Leslie W. Organ · Oct 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
K002565 · Baylis Medical Co., Inc. · May 2001