Clearance Summary
STORZ RANEY SCALP CLIP, MODEL 1-20-004-05 received FDA 510(k) clearance under submission number K033660, sponsored by Rudolf Storz 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 2004-01-07.
- Submission: K033660
- Applicant / Sponsor: Rudolf Storz GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4150
- Decision date: 2004-01-07
Classification & Regulation
This clearance is catalogued under FDA product code HBO and 21 CFR 882.4150, within the Neurology review panel as a Class II device.