RenaPure Endotoxin Retentive Filter

RenaPure Endotoxin Retentive Filter is an FDA 510(k)-cleared medical device (K231410) manufactured by Evoqua Water Technologies, LLC. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 18, 2023. Regulation: 8.