Clearance Summary
LEKSELL STEREOACTIC SYSTEM received FDA 510(k) clearance under submission number K811726, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1981-07-10.
- Submission: K811726
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1981-07-10
Classification & Regulation
This clearance is catalogued under FDA product code LHF and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.