Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043398

FEI Number

3003630373

Entity Name

DIROS TECHNOLOGY, INC.

City/State/Country

MARKHAM Ontario, CA

Establishment Address

120 GIBSON DRIVE, MARKHAM Ontario L3R 2Z3, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIROS TECHNOLOGY, INC. (Owner Number: 9001301)

Owner / Operator Contact Address

120 GIBSON DRIVE, MARKHAM, CA-ON L3R 2Z3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OWL STERILE SINGLE USE DISPOSABLE CANNULA OWL RF SYSTEM, URF-1A DIROS OWL URF-3AP(ML) OWL URF-3AP OWL GD-PAD PATIENT RETURN ELECTRODE OWL Single Use Disposable RF Probes/Temperature Sensors OWL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2011-06-15
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2008-02-12
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2010-03-19
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	1990-10-05
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	1990-10-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-03-17
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2011-05-12
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2016-07-05

Official Correspondent

Paul Needler

US Agent Details

Amy Winegarden Business: Avanos Medical, Inc. Email: RegulatoryAffairsNA@avanos.com Phone: (412) 9773427

Related Public Records

Same Entity

DIROS TECHNOLOGY, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
Z-0664-2020	Abbott Medical	2	Radiofrequency Grounding Pad, REF RF-DGP-L
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
3010034260	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Santa Rosa, CA, US
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043398. Last updated year: 2026. Please use registration number 8043398 when referencing this establishment in official correspondence.