Clearance Summary
MOONCUP, STYLE A & B received FDA 510(k) clearance under submission number K040335, sponsored by Mooncup, LLC. 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 2005-03-30.
- Submission: K040335
- Applicant / Sponsor: Mooncup, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5400
- Decision date: 2005-03-30
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.