Clearance Summary
ROVERS ENDOCERVEX-BRUSH received FDA 510(k) clearance under submission number K001119, sponsored by Rovers Medical Devices B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-05-19.
- Submission: K001119
- Applicant / Sponsor: Rovers Medical Devices B.V.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2000-05-19
Classification & Regulation
This clearance is catalogued under FDA product code HHT and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.