Cleared Special

K062758 - OWL URF-3AP

K062758 is an FDA 510(k) clearance for OWL URF-3AP, 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 12-day FDA review.

K062758 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
12d
Days
Class 2
Risk

K062758 is an FDA 510(k) clearance for the OWL URF-3AP. 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 September 27, 2006 after a review of 12 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 - K062758

510(k) Number K062758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2006
Decision Date September 27, 2006
Days to Decision 12 days
Submission Type Special
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
137d faster than avg
Panel avg: 149d · This submission: 12d
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 K062758.
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