Data / Medical devices / Canada / Diros Technology, Inc.
Diros Technology, Inc.: FDA-registered device maker in MARKHAM Ontario, Canada, 10 510(k) clearances
Diros Technology, Inc. is registered with the FDA (registration 8043398) in MARKHAM Ontario, Canada. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 27, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043398
- FEI number
- 3003630373
- Address
- 120 Gibson Drive, MARKHAM Ontario, Canada, L3R 2Z3
- Owner or operator
- DIROS TECHNOLOGY, INC. (9001301)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 5, 1990
- Registered through
- 2026
- Brand names listed
- DIROS OWL URF-3AP(ML), OWL, OWL GD-PAD PATIENT RETURN ELECTRODE, OWL RF SYSTEM, URF-1A, OWL STERILE SINGLE USE DISPOSABLE CANNULA, OWL STERILE SINGLE USE RF INSULATED CANNULAE, MODEL 466 AND DHC, OWL Single Use Disposable RF Probes/Temperature Sensors, OWL URF-3AP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Depth | GZL | 2 | Manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Generator, Lesion, Radiofrequency | GXD | 2 | Manufacturer | accessdata.fda.gov |
| Probe, Radiofrequency Lesion | GXI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2017 | K170708 | OWL RF INSULATED CANNULAE | GXI | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| July 30, 2015 | K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH | GXI | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| December 30, 2014 | K141586 | OWL CANNULAE | GXI | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| June 3, 2011 | K102566 | OWL CANNULAE | GXI | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| May 5, 2011 | K110593 | OWL RF PROBES | GXI | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| January 22, 2010 | K093185 | OWL UNIVERSAL RF SYSTEM URF-3AP (ML) | GXD | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| December 19, 2007 | K073360 | PROPLATE | GEI | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| September 27, 2006 | K062758 | OWL URF-3AP | GXD | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| July 1, 2002 | K021869 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP | GXD | Substantially Equivalent | Diros Technology, Inc. | accessdata.fda.gov |
| October 31, 2001 | K010202 | OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES | GXD | Substantially Equivalent | Leslie W. Organ | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Lesion, Radiofrequency
- All makers of Probe, Radiofrequency Lesion
- All makers of Electrode, Depth
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Cable, Electrode
Updated June 27, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.