510(k) K142432

StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit by Bioness, Inc. — Product Code GZF

K142432 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit". The FDA issued a decision of Substantially Equivalent on February 20, 2015. The device falls under product code GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5870. Bioness, Inc. has at least 10 other 510(k) clearances on record.