Clearance Summary
Optiflux Enexa F500 Dialyzer received FDA 510(k) clearance under submission number K192928, sponsored by Fresenius Medical Care Reanal Therapies Group, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-07-09.
- Submission: K192928
- Applicant / Sponsor: Fresenius Medical Care Reanal Therapies Group, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2020-07-09
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.