Clearance Summary
S698 Symbioz flow received FDA 510(k) clearance under submission number K153367, sponsored by Sopro - Acteon Group. 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 2016-06-17.
- Submission: K153367
- Applicant / Sponsor: Sopro - Acteon Group
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2016-06-17
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.