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FDA 510(k)

EndoPur Filter

K-Number: K161304 · 2017-03-02

ApplicantNephros, Inc.
Decision Date2017-03-02
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoPur Filter is a medical device manufactured by Nephros, Inc.. It received FDA 510(k) clearance on 2017-03-02 under approval number K161304. 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 EndoPur Filter?

EndoPur Filter is a medical device that received FDA 510(k) clearance on 2017-03-02. It is manufactured by Nephros, Inc.. The 510(k) number is K161304.

When was EndoPur Filter approved by the FDA?

EndoPur Filter received FDA 510(k) clearance on 2017-03-02, under approval number K161304.

What company makes EndoPur Filter?

EndoPur Filter is manufactured by Nephros, Inc..

What is the FDA product code for EndoPur Filter?

The FDA product code for EndoPur Filter is FIP.

Other Devices by Nephros, Inc.

K161467HydraGuard 10 UltraFilter K153084Nephros S100

Related Devices (Code: FIP)

K161844Matrix Pre-Treatment ControllerBetter Water, LLC K153329MED-TECH Water Systems Inc Exchangeable Carbon Tanks for DialysisMed-Tech Water Systems, Inc. K171099EON Portable Reverse Osmosis Water Purification SystemCantel K192398Millenium HXMar Cor Purification, Inc. K182367DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC K200670EON Portable RO Water Purification SystemMar Cor Purification, Inc.

Official Source

View on FDA Database →

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

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