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FDA 510(k)

ClariFix Device

K-Number: K160669 · 2016-06-24

ApplicantArrinex, Inc.
Decision Date2016-06-24
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 2016-06-24 under approval number K160669. 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 2016-06-24. It is manufactured by Arrinex, Inc.. The 510(k) number is K160669.

When was ClariFix Device approved by the FDA?

ClariFix Device received FDA 510(k) clearance on 2016-06-24, under approval number K160669.

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.

K162608ClariFix Device K190356ClariFix

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Official Source

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