Clearance Summary
ulrichINJECT CT Motion (XD 8000) received FDA 510(k) clearance under submission number K251295, sponsored by Ulrich GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2025-11-07.
- Submission: K251295
- Applicant / Sponsor: Ulrich GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2025-11-07
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.