Clearance Summary
NEUROGEN NERVE GUIDE received FDA 510(k) clearance under submission number K011168, sponsored by Integra Lifesciences 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 2001-06-22.
- Submission: K011168
- Applicant / Sponsor: Integra Lifesciences Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5275
- Decision date: 2001-06-22
Classification & Regulation
This clearance is catalogued under FDA product code JXI and 21 CFR 882.5275, within the Neurology review panel as a Class II device.