Clearance Summary
MOONCUP received FDA 510(k) clearance under submission number K060852, sponsored by Mooncup Limited. 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 2006-12-26.
- Submission: K060852
- Applicant / Sponsor: Mooncup Limited
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5400
- Decision date: 2006-12-26
Classification & Regulation
This clearance is catalogued under FDA product code HHE and 21 CFR 884.5400, within the Obstetrics/Gynecology review panel as a Class II device.