Clearance Summary
Sydney IVF Gamete Buffer received FDA 510(k) clearance under submission number K153478, sponsored by William A. Cook Australia Pty. , Ltd.. 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 2016-08-15.
- Submission: K153478
- Applicant / Sponsor: William A. Cook Australia Pty. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2016-08-15
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.