Clearance Summary
SUNDT-KEES REINFORCING ANEURYSM CLIP received FDA 510(k) clearance under submission number K844352, sponsored by Kees Surgical Specialty Co., 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 1985-01-24.
- Submission: K844352
- Applicant / Sponsor: Kees Surgical Specialty Co., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5200
- Decision date: 1985-01-24
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.