Owl Cannulae
FDA 510(k) K102566 · Diros Technology, Inc.
510(k) numberK102566
Submission
- Device name
- Owl Cannulae
- Applicant
- Diros Technology, Inc.
Markham, Ontario, CA - Received
- September 7, 2010
- Decision date
- June 3, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K190259 | Vesta RF CannulaGXI · Special | Biomerics | 02/07/2020SE |
More from Biomerics
| 510(k) | Device | Decision |
|---|---|---|
| K170708 | Owl RF Insulated CannulaeGXI · Special | 06/27/2017SE |
| K150371 | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRHGXI · Traditional | 07/30/2015SE |
| K141586 | Owl CannulaeGXI · Traditional | 12/30/2014SE |
| K110593 | Owl RF ProbesGXI · Special | 05/05/2011SE |
| K093185 | Owl Universal RF System URF-3AP (ML)GXD · Traditional | 01/22/2010SE |
| K062758 | Owl URF-3APGXD · Special | 09/27/2006SE |
| K021869 | Owl Radiofrequency System, Model URF-2APGXD · Special | 07/01/2002SE |
Questions and answers
When was Owl Cannulae cleared by the FDA?
Owl Cannulae (K102566) received a 510(k) decision of Substantially Equivalent on June 3, 2011, 269 days after the submission was received.
What is the product code of K102566?
The FDA product code is GXI – Probe, Radiofrequency Lesion, a Class II (moderate risk) device regulated under 21 CFR 882.4725.