Cleared Traditional

K010202 - OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES

K010202 is an FDA 510(k) clearance for OWL RADIOFREQUENCY SYSTEM, manufactured by Leslie W. Organ. The device is a Class 2 Neurology device with product code GXD cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K010202 · Leslie W. Organ · Neurology device
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Oct 2001
Decision
282d
Days
Class 2
Risk

K010202 is an FDA 510(k) clearance for the OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION .... Classified as Generator, Lesion, Radiofrequency (product code GXD), Class II - Special Controls.

Submitted by Leslie W. Organ (Charleston, US). The FDA issued a Cleared decision on October 31, 2001 after a review of 282 days - an extended review cycle.

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.

View all Leslie W. Organ devices

FDA 510(k) Submission Details - K010202

510(k) Number K010202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date October 31, 2001
Days to Decision 282 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
134d slower than avg
Panel avg: 148d · This submission: 282d
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 25
Devices cleared under the same product code (GXD) and FDA review panel - the closest regulatory comparables to K010202.
STRYKER INTRADISCAL RF GENERATOR
K063489 · Synergetics, Inc. · May 2007
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
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
K002565 · Baylis Medical Co., Inc. · May 2001
NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES
K010969 · Stryker Instruments · Apr 2001
RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES
K983214 · Rita Medical Systems · Mar 2000