FDA.reportPublic FDA data

510(k) K150371

Device
Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR And DTRH
Applicant
DIROS TECHNOLOGY, INC.
510(k) number
K150371
Product code
GXI  
Decision
Substantially Equivalent (SESE)
Decision date
2015-07-30
Date received
2015-02-13
Regulation
882.4725
Classification name
Probe, Radiofrequency Lesion
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GEORGE DARMOS
Address
120 Gibson Dr. Markham CA L3R 2Z3 L3R 2Z3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253907Disposable Radiofrequency CannulaABBOTT MEDICAL2026-04-16
K251802STAR RF Ablation SystemMerit Medical Systems, Inc.2026-02-13
K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.2025-08-15
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL2025-05-27
K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments2025-05-15
K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.2025-01-23
K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022-10-26
K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022-03-11
K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc.2020-12-22
K190259Vesta RF CannulaBiomerics2020-02-07
K191293LCCS VC-S RF CannulaLccs Products Limited2020-01-24
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF GeneratorRelievant Medsystems2019-05-03
K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.2019-03-08
K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation2019-03-08
K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems2018-09-14

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases