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FDA 510(k)

ClariFix Device

K-Number: K162608 · 2017-02-14

ApplicantArrinex, Inc.
Decision Date2017-02-14
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ClariFix Device is a medical device manufactured by Arrinex, Inc.. It received FDA 510(k) clearance on 2017-02-14 under approval number K162608. 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 Device?

ClariFix Device is a medical device that received FDA 510(k) clearance on 2017-02-14. It is manufactured by Arrinex, Inc.. The 510(k) number is K162608.

When was ClariFix Device approved by the FDA?

ClariFix Device received FDA 510(k) clearance on 2017-02-14, under approval number K162608.

What company makes ClariFix Device?

ClariFix Device is manufactured by Arrinex, Inc..

What is the FDA product code for ClariFix Device?

The FDA product code for ClariFix Device is GEH.

Other Devices by Arrinex, Inc.

K160669ClariFix Device K190356ClariFix

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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.

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