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FDA 510(k)

ClariFix

K-Number: K190356 · 2019-02-26

ApplicantArrinex, Inc.
Decision Date2019-02-26
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ClariFix is a medical device manufactured by Arrinex, Inc.. It received FDA 510(k) clearance on 2019-02-26 under approval number K190356. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClariFix?

ClariFix is a medical device that received FDA 510(k) clearance on 2019-02-26. It is manufactured by Arrinex, Inc.. The 510(k) number is K190356.

When was ClariFix approved by the FDA?

ClariFix received FDA 510(k) clearance on 2019-02-26, under approval number K190356.

What company makes ClariFix?

ClariFix is manufactured by Arrinex, Inc..

What is the FDA product code for ClariFix?

The FDA product code for ClariFix is GEH.

Other Devices by Arrinex, Inc.

K160669ClariFix Device K162608ClariFix Device

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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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