Clearance Summary
CYTOASPIRATOR received FDA 510(k) clearance under submission number K902910, sponsored by H & B Medical Technology, Inc.. 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 1991-01-16.
- Submission: K902910
- Applicant / Sponsor: H & B Medical Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 1991-01-16
Classification & Regulation
This clearance is catalogued under FDA product code FCK and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.