Clearance Summary
Berkeley VC-10 Vacuum Curettage System received FDA 510(k) clearance under submission number K171440, sponsored by Gyrus Acmi. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2017-09-29.
- Submission: K171440
- Applicant / Sponsor: Gyrus Acmi
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 2017-09-29
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.