Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

System, Water Purification, General Medical Use

FDA product code NHV · 11 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5665
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2002-05-07 – 2026-09-09

The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis. The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists. Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.

↑