Clearance Summary
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 received FDA 510(k) clearance under submission number K002970, sponsored by Medical Designs, 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 2000-12-12.
- Submission: K002970
- Applicant / Sponsor: Medical Designs, LLC
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 2000-12-12
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.