Clearance Summary
SpaceOAR System received FDA 510(k) clearance under submission number K202224, sponsored by Boston Scientific Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-08-28.
- Submission: K202224
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5725
- Decision date: 2020-08-28
Classification & Regulation
This clearance is catalogued under FDA product code OVB and 21 CFR 892.5725, within the Radiology review panel as a Class II device.