Clearance Summary
BERKELEY V-10 VACUUM CURETTAGE SYSTEM received FDA 510(k) clearance under submission number K030935, sponsored by Acmi Corporation. 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 2003-06-23.
- Submission: K030935
- Applicant / Sponsor: Acmi Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 2003-06-23
Classification & Regulation
This clearance is catalogued under FDA product code HHI and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.