Clearance Summary
RANEY AND LEROY-RANEY SCALP CLIP received FDA 510(k) clearance under submission number K883963, sponsored by New England Surgical Instrument Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-10-07.
- Submission: K883963
- Applicant / Sponsor: New England Surgical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4150
- Decision date: 1988-10-07
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.