Clearance Summary
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY received FDA 510(k) clearance under submission number K133299, sponsored by Fresenius Medical Care, North America - Renal Ther. 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 2014-07-07.
- Submission: K133299
- Applicant / Sponsor: Fresenius Medical Care, North America - Renal Ther
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2014-07-07
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.