Clearance Summary
Synvitro Hyadase received FDA 510(k) clearance under submission number K200680, sponsored by Origio A/S, A Coopersurgical Company. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2020-07-17.
- Submission: K200680
- Applicant / Sponsor: Origio A/S, A Coopersurgical Company
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2020-07-17
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.