Clearance Summary
STERILE SUBDERMAL NEEDLE ELECTRODES received FDA 510(k) clearance under submission number K010019, sponsored by Nicolet Biomedical, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-03-19.
- Submission: K010019
- Applicant / Sponsor: Nicolet Biomedical, Inc.
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1350
- Decision date: 2001-03-19
Classification & Regulation
This clearance is catalogued under FDA product code GXZ and 21 CFR 882.1350, within the Neurology review panel as a Class II device.