Cleared Traditional

K141586 - OWL CANNULAE

K141586 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 200-day FDA review.

K141586 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
200d
Days
Class 2
Risk

K141586 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,On, CA). The FDA issued a Cleared decision on December 30, 2014 after a review of 200 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 - K141586

510(k) Number K141586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2014
Decision Date December 30, 2014
Days to Decision 200 days
Submission Type Traditional
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
51d slower than avg
Panel avg: 149d · This submission: 200d
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 K141586.
LCCS Disposable RF Electrode, LCCS Reusable RF Electrode
K152642 · Lccs Products Limited · Aug 2016
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
K153272 · Relievant Medsystems · Jul 2016
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
K150371 · Diros Technology, Inc. · Jul 2015
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