Cleared Traditional

K150371 - Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH

K150371 is an FDA 510(k) clearance for Diros OWL Sterile Single Use TridentTM ..., 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 167-day FDA review.

K150371 · Diros Technology, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
167d
Days
Class 2
Risk

K150371 is an FDA 510(k) clearance for the Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and.... 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 July 30, 2015 after a review of 167 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 - K150371

510(k) Number K150371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2015
Decision Date July 30, 2015
Days to Decision 167 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
18d slower than avg
Panel avg: 149d · This submission: 167d
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 K150371.
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OWL CANNULAE
K141586 · Diros Technology, Inc. · Dec 2014
STRYKER VENOM ELECTRODES AND CANNULAE
K123178 · Stryker Instruments, Instruments Div. · Mar 2013
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773 · Biomerics · Sep 2012