510(k) K231410

RenaPure Endotoxin Retentive Filter by Evoqua Water Technologies, LLC — Product Code FIP

K231410 is an FDA 510(k) premarket notification submitted by Evoqua Water Technologies, LLC for the device "RenaPure Endotoxin Retentive Filter". The FDA issued a decision of Substantially Equivalent on July 19, 2023. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Evoqua Water Technologies, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2023
Date Received
May 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type