510(k) K170708

OWL RF INSULATED CANNULAE by Diros Technology, Inc. — Product Code GXI

K170708 is an FDA 510(k) premarket notification submitted by Diros Technology, Inc. for the device "OWL RF INSULATED CANNULAE". The FDA issued a decision of Substantially Equivalent on June 27, 2017. 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.