Clearance Summary
SPOTLIGHT ACCESS SYSTEM received FDA 510(k) clearance under submission number K112913, sponsored by Johnson & Johnson. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-12-16.
- Submission: K112913
- Applicant / Sponsor: Johnson & Johnson
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 2011-12-16
Classification & Regulation
This clearance is catalogued under FDA product code GZT and 21 CFR 882.4800, within the Neurology review panel as a Class II device.