Clearance Summary
SCKOONCUP received FDA 510(k) clearance under submission number K120107, sponsored by Sckoon, Inc.. 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 2012-09-18.
- Submission: K120107
- Applicant / Sponsor: Sckoon, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5400
- Decision date: 2012-09-18
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.