510(k) K150371

Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH by Diros Technology, Inc. — Product Code GXI

K150371 is an FDA 510(k) premarket notification submitted by Diros Technology, Inc. for the device "Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH". The FDA issued a decision of Substantially Equivalent on July 30, 2015. 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.