Clearance Summary
MAYFIELD DISPOSABLE SKULL PINS received FDA 510(k) clearance under submission number K853066, 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 1985-08-08.
- Submission: K853066
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5960
- Decision date: 1985-08-08
Classification & Regulation
This clearance is catalogued under FDA product code HAX and 21 CFR 882.5960, within the Neurology review panel as a Class II device.