Cleared Traditional

K102566 - OWL CANNULAE

K102566 is an FDA 510(k) clearance for OWL CANNULAE, manufactured by Diros Technology, Inc.. The device is a Class 2 Neurology device with product code GXI cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K102566 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
269d
Days
Class 2
Risk

K102566 is an FDA 510(k) clearance for the OWL CANNULAE. 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 June 3, 2011 after a review of 269 days - an extended review cycle.

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

FDA 510(k) Submission Details - K102566

510(k) Number K102566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date June 03, 2011
Days to Decision 269 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
120d slower than avg
Panel avg: 149d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K102566.
STRYKER VENOM ELECTRODES AND CANNULAE
K123178 · Stryker Instruments, Instruments Div. · Mar 2013
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773 · Biomerics · Sep 2012
LCCS INSULATED SPINAL NEEDLE (RF CANNULA)
K112231 · Lccs Products Limited · Aug 2011
OWL RF PROBES
K110593 · Diros Technology, Inc. · May 2011
DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20
K101372 · Baylis Medical Co., Inc. · Aug 2010
MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B)
K090608 · Minta Medical Limited · Jun 2010