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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 the device name listed in this FDA 510(k) record. The listed applicant is Arrinex, Inc.. It received FDA 510(k) clearance on 2019-02-26 under 510(k) 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. The listed applicant is Arrinex, Inc.. The 510(k) number is K190356.

When did ClariFix receive FDA 510(k) clearance?

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

Who is the listed applicant for ClariFix?

The FDA 510(k) record lists Arrinex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClariFix?

The FDA product code for ClariFix is GEH.

Other records listing Arrinex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162608ClariFix DeviceK160669ClariFix Device

Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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