Clearance Summary
EmbryoSlide+ ic8 dish received FDA 510(k) clearance under submission number K213869, sponsored by Vitrolife 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 2022-03-11.
- Submission: K213869
- Applicant / Sponsor: Vitrolife A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6160
- Decision date: 2022-03-11
Classification & Regulation
This clearance is catalogued under FDA product code MQK and 21 CFR 884.6160, within the Obstetrics/Gynecology review panel as a Class II device.