Clearance Summary
TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM received FDA 510(k) clearance under submission number K093973, 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 2010-05-26.
- Submission: K093973
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2010-05-26
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.