Clearance Summary
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR received FDA 510(k) clearance under submission number K821772, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1982-09-28.
- Submission: K821772
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 1982-09-28
Classification & Regulation
This clearance is catalogued under FDA product code HBL and 21 CFR 882.4460, within the Neurology review panel as a Class II device.