Clearance Summary
CN-Suite received FDA 510(k) clearance under submission number K260563, sponsored by FIND Surgical Sciences Inc. D/B/A FIND Neuro. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-08-16.
- Submission: K260563
- Applicant / Sponsor: FIND Surgical Sciences Inc. D/B/A FIND Neuro
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2026-08-16
Classification & Regulation
This clearance is catalogued under FDA product code OLX and 21 CFR 882.1400, within the Neurology review panel as a Class II device.