FDA 510(k)

RenaPure Endotoxin Retentive Filter

K-Number: K231410 · 2023-07-19

Decision Date2023-07-19

Product CodeFIP

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RenaPure Endotoxin Retentive Filter is a medical device manufactured by Evoqua Water Technologies, LLC. It received FDA 510(k) clearance on 2023-07-19 under approval number K231410. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RenaPure Endotoxin Retentive Filter?

RenaPure Endotoxin Retentive Filter is a medical device that received FDA 510(k) clearance on 2023-07-19. It is manufactured by Evoqua Water Technologies, LLC. The 510(k) number is K231410.

When was RenaPure Endotoxin Retentive Filter approved by the FDA?

RenaPure Endotoxin Retentive Filter received FDA 510(k) clearance on 2023-07-19, under approval number K231410.

What company makes RenaPure Endotoxin Retentive Filter?

RenaPure Endotoxin Retentive Filter is manufactured by Evoqua Water Technologies, LLC.

What is the FDA product code for RenaPure Endotoxin Retentive Filter?

The FDA product code for RenaPure Endotoxin Retentive Filter is FIP.

Other Devices by Evoqua Water Technologies, LLC

K153784NOSOGARD FILTERS

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.