Clearance Summary
GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 received FDA 510(k) clearance under submission number K092963, sponsored by Genx Intl., 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 2011-01-14.
- Submission: K092963
- Applicant / Sponsor: Genx Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2011-01-14
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.