Clearance Summary
REBSTOCK YASARGIL ANEURYSM CLIP received FDA 510(k) clearance under submission number K003500, sponsored by Rebstock - Instrumente GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-05-30.
- Submission: K003500
- Applicant / Sponsor: Rebstock - Instrumente GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5200
- Decision date: 2001-05-30
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.