Clearance Summary
EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS received FDA 510(k) clearance under submission number K972994, sponsored by Integra Neurocare, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1997-11-03.
- Submission: K972994
- Applicant / Sponsor: Integra Neurocare, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 1997-11-03
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.