Clearance Summary
LEKSELL STEREOTACTIC SYSTEM received FDA 510(k) clearance under submission number K802140, sponsored by Downs Surgical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-02-05.
- Submission: K802140
- Applicant / Sponsor: Downs Surgical , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1920
- Decision date: 1981-02-05
Classification & Regulation
This clearance is catalogued under FDA product code IWY and 21 CFR 892.1920, within the Radiology review panel as a Class I device.