Clearance Summary
CELL SWEEP received FDA 510(k) clearance under submission number K911327, sponsored by Reza S Mohajer, M.D. C/O Krass & Young. 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 1991-05-21.
- Submission: K911327
- Applicant / Sponsor: Reza S Mohajer, M.D. C/O Krass & Young
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1991-05-21
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.