Clearance Summary
POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM received FDA 510(k) clearance under submission number K070759, sponsored by Vidacare Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2007-05-21.
- Submission: K070759
- Applicant / Sponsor: Vidacare Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2007-05-21
Classification & Regulation
This clearance is catalogued under FDA product code FCF and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.