Clearance Summary
IGUIDE CAPPA received FDA 510(k) clearance under submission number K093787, sponsored by Cas Innovations 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 2010-03-11.
- Submission: K093787
- Applicant / Sponsor: Cas Innovations GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2010-03-11
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.