Clearance Summary
SICAT Implant V2.0 received FDA 510(k) clearance under submission number K192348, sponsored by Sicat GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2019-12-04.
- Submission: K192348
- Applicant / Sponsor: Sicat GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2019-12-04
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.