Clearance Summary
FILTRAY 2G Disposable Water Filters received FDA 510(k) clearance under submission number K191563, sponsored by Aqua-Tools. 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 2019-10-25.
- Submission: K191563
- Applicant / Sponsor: Aqua-Tools
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2019-10-25
Classification & Regulation
This clearance is catalogued under FDA product code NHV and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.