Clearance Summary
CONFIDENT SURGERY SUITE 300, MODEL CSS300 received FDA 510(k) clearance under submission number K101887, sponsored by Surgiceye GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-03-22.
- Submission: K101887
- Applicant / Sponsor: Surgiceye GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1320
- Decision date: 2011-03-22
Classification & Regulation
This clearance is catalogued under FDA product code IZD and 21 CFR 892.1320, within the Radiology review panel as a Class I device.