Clearance Summary
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit received FDA 510(k) clearance under submission number K142432, sponsored by Bioness, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-02-20.
- Submission: K142432
- Applicant / Sponsor: Bioness, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5870
- Decision date: 2015-02-20
Classification & Regulation
This clearance is catalogued under FDA product code GZF and 21 CFR 882.5870, within the Neurology review panel as a Class II device.