NHV

System, Water Purification, General Medical Use

Product code

NHV

Device name

System, Water Purification, General Medical Use

Device class

Class 2

21 CFR

21 CFR 876.5665

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

11 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).