Cleared Special

K170708 - OWL RF INSULATED CANNULAE

K170708 is an FDA 510(k) clearance for OWL RF INSULATED CANNULAE, 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 111-day FDA review.

K170708 · Diros Technology, Inc. · Neurology device
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Jun 2017
Decision
111d
Days
Class 2
Risk

K170708 is an FDA 510(k) clearance for the OWL RF INSULATED CANNULAE. Classified as Probe, Radiofrequency Lesion (product code GXI), Class II - Special Controls.

Submitted by Diros Technology, Inc. (Markham, CA). The FDA issued a Cleared decision on June 27, 2017 after a review of 111 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K170708

510(k) Number K170708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2017
Decision Date June 27, 2017
Days to Decision 111 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
38d faster than avg
Panel avg: 149d · This submission: 111d
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 65
Devices cleared under the same product code (GXI) and FDA review panel - the closest regulatory comparables to K170708.
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