Clearance Summary
CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY received FDA 510(k) clearance under submission number K942843, sponsored by Rovers Diagnostic Devices. 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 1994-12-08.
- Submission: K942843
- Applicant / Sponsor: Rovers Diagnostic Devices
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-12-08
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.