Cleared Traditional

RenaPure Endotoxin Retentive Filter

K231410 · Evoqua Water Technologies, LLC · Gastroenterology & Urology

Jul 2023

Decision

65d

Days

Class 2

Risk

About This 510(k) Submission

K231410 is an FDA 510(k) clearance for the RenaPure Endotoxin Retentive Filter, a Subsystem, Water Purification (Class II — Special Controls, product code FIP), submitted by Evoqua Water Technologies, LLC (Tewksbury, US). The FDA issued a Cleared decision on July 19, 2023, 65 days after receiving the submission on May 15, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number	K231410 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2023
Decision Date	July 19, 2023
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF