Clearance Summary
GuardianTM Burr Hole Cover System received FDA 510(k) clearance under submission number K181382, sponsored by St Jude Medical. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-07-20.
- Submission: K181382
- Applicant / Sponsor: St Jude Medical
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5250
- Decision date: 2018-07-20
Classification & Regulation
This clearance is catalogued under FDA product code GXR and 21 CFR 882.5250, within the Neurology review panel as a Class II device.