Clearance Summary
Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs received FDA 510(k) clearance under submission number K161154, sponsored by Spr Therapeutics, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-07-23.
- Submission: K161154
- Applicant / Sponsor: Spr Therapeutics, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2016-07-23
Classification & Regulation
This clearance is catalogued under FDA product code NHI and 21 CFR 882.5890, within the Neurology review panel as a Class II device.