Clearance Summary
Transem and EchoGen Embryo Transfer Catheters received FDA 510(k) clearance under submission number K161547, sponsored by Origio 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 2017-03-09.
- Submission: K161547
- Applicant / Sponsor: Origio A/S
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6110
- Decision date: 2017-03-09
Classification & Regulation
This clearance is catalogued under FDA product code MQF and 21 CFR 884.6110, within the Obstetrics/Gynecology review panel as a Class II device.