Clearance Summary
CODMAN DISPOSABLE SKULL PINS received FDA 510(k) clearance under submission number K911723, 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 1991-09-10.
- Submission: K911723
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 1991-09-10
Classification & Regulation
This clearance is catalogued under FDA product code HBL and 21 CFR 882.4460, within the Neurology review panel as a Class II device.