Clearance Summary
KELLY-GROERSS-KALL CT STEROTACTIC ADAPTATION SYS received FDA 510(k) clearance under submission number K852477, sponsored by Mayo Clinic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1985-07-30.
- Submission: K852477
- Applicant / Sponsor: Mayo Clinic
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 1985-07-30
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.