FDA 510(k)

Velacur

K-Number: K223287 · 2023-04-20

Decision Date2023-04-20

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Velacur is a medical device manufactured by Sonic Incytes. It received FDA 510(k) clearance on 2023-04-20 under approval number K223287. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velacur?

Velacur is a medical device that received FDA 510(k) clearance on 2023-04-20. It is manufactured by Sonic Incytes. The 510(k) number is K223287.

When was Velacur approved by the FDA?

Velacur received FDA 510(k) clearance on 2023-04-20, under approval number K223287.

What company makes Velacur?

Velacur is manufactured by Sonic Incytes.

What is the FDA product code for Velacur?

The FDA product code for Velacur is IYO.

Other Devices by Sonic Incytes

K201597Liver Incytes, Model 1005 K232459Velacur K233977Velacur

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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.