Clearance Summary
SPOTLIGHT ACCESS SYSTEM received FDA 510(k) clearance under submission number K113273, sponsored by Johnson & Johnson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-01-27.
- Submission: K113273
- Applicant / Sponsor: Johnson & Johnson
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4800
- Decision date: 2012-01-27
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.