Clearance Summary
Gems Oocyte Retrieval Buffer ORB-20, ORB-50 received FDA 510(k) clearance under submission number K170498, sponsored by Genea Biomedx 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 2017-09-28.
- Submission: K170498
- Applicant / Sponsor: Genea Biomedx Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2017-09-28
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.