Cleared Special

K110593 - OWL RF PROBES

K110593 is an FDA 510(k) clearance for OWL RF PROBES, manufactured by Diros Technology, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Special 510(k) pathway after a 64-day FDA review.

K110593 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
64d
Days
Class 2
Risk

K110593 is an FDA 510(k) clearance for the OWL RF PROBES. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Diros Technology, Inc. (Markham, Ontario, CA). The FDA issued a Cleared decision on May 5, 2011 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4725 - 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.

View all Diros Technology, Inc. devices

FDA 510(k) Submission Details - K110593

510(k) Number K110593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date May 05, 2011
Days to Decision 64 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 148d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

GXI Device Classification - Class 2, Special Controls

Product Code GXI Probe, Radiofrequency Lesion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4725
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 - GXI Probe, Radiofrequency Lesion

All 39
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K110593.
Nitinol Thermocouple (TCN) Electrode
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Rulo Radiofrequency Lesion Probe
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DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc. · Aug 2010
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · Baylis Medical Co., Inc. · Oct 2009
SMITH & NEPHEW RF CANNULATE
K090955 · Smith & Nephew, Inc. · Jul 2009