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FDA 510(k)

ArtiFascia

K-Number: K223445 · 2023-08-10

ApplicantNurami Medical , Ltd.
Decision Date2023-08-10
Product CodeGXQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ArtiFascia is a medical device manufactured by Nurami Medical , Ltd.. It received FDA 510(k) clearance on 2023-08-10 under approval number K223445. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtiFascia?

ArtiFascia is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Nurami Medical , Ltd.. The 510(k) number is K223445.

When was ArtiFascia approved by the FDA?

ArtiFascia received FDA 510(k) clearance on 2023-08-10, under approval number K223445.

What company makes ArtiFascia?

ArtiFascia is manufactured by Nurami Medical , Ltd..

What is the FDA product code for ArtiFascia?

The FDA product code for ArtiFascia is GXQ.

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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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