FDA 510(k)

EndoCore

K-Number: K230778 · 2023-09-25

Decision Date2023-09-25

Product CodeKTI

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

EndoCore is a medical device manufactured by Praxis Medical, LLC. It received FDA 510(k) clearance on 2023-09-25 under approval number K230778. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoCore?

EndoCore is a medical device that received FDA 510(k) clearance on 2023-09-25. It is manufactured by Praxis Medical, LLC. The 510(k) number is K230778.

When was EndoCore approved by the FDA?

EndoCore received FDA 510(k) clearance on 2023-09-25, under approval number K230778.

What company makes EndoCore?

EndoCore is manufactured by Praxis Medical, LLC.

What is the FDA product code for EndoCore?

The FDA product code for EndoCore is KTI.

Other Devices by Praxis Medical, LLC

K200278CytoCore

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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.