Clearance Summary
EMBRYOASSIST received FDA 510(k) clearance under submission number K061309, sponsored by Medicult A/S. 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 2007-02-08.
- Submission: K061309
- Applicant / Sponsor: Medicult A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2007-02-08
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.