Clearance Summary
DURAFORM Dural Graft Implant received FDA 510(k) clearance under submission number K152481, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-10-30.
- Submission: K152481
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5910
- Decision date: 2015-10-30
Classification & Regulation
This clearance is catalogued under FDA product code GXQ and 21 CFR 882.5910, within the Neurology review panel as a Class II device.