510(k) K141586
K141586 is an FDA 510(k) premarket notification submitted by Diros Technology, Inc. for the device "OWL CANNULAE". The FDA issued a decision of Substantially Equivalent on December 30, 2014. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Diros Technology, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2014
- Date Received
- June 13, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type