Clearance Summary
SCOVILLE-LEWIS ANEURYSM CLIPS received FDA 510(k) clearance under submission number K791764, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1979-10-01.
- Submission: K791764
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5200
- Decision date: 1979-10-01
Classification & Regulation
This clearance is catalogued under FDA product code HCH and 21 CFR 882.5200, within the Neurology review panel as a Class II device.