Clearance Summary
ENDOBRUSH(TM) DEVICE; OMNIBRUSH received FDA 510(k) clearance under submission number K897070, sponsored by Intl. Cytobrush, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1990-09-10.
- Submission: K897070
- Applicant / Sponsor: Intl. Cytobrush, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1100
- Decision date: 1990-09-10
Classification & Regulation
This clearance is catalogued under FDA product code HFE and 21 CFR 884.1100, within the Obstetrics/Gynecology review panel as a Class II device.