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FDA 510(k)

Encora X1

K-Number: K251517 · 2026-02-05

ApplicantEncora, Inc.
Decision Date2026-02-05
Product CodeQBC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Encora X1 is a medical device manufactured by Encora, Inc.. It received FDA 510(k) clearance on 2026-02-05 under approval number K251517. The device is classified under product code QBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Encora X1?

Encora X1 is a medical device that received FDA 510(k) clearance on 2026-02-05. It is manufactured by Encora, Inc.. The 510(k) number is K251517.

When was Encora X1 approved by the FDA?

Encora X1 received FDA 510(k) clearance on 2026-02-05, under approval number K251517.

What company makes Encora X1?

Encora X1 is manufactured by Encora, Inc..

What is the FDA product code for Encora X1?

The FDA product code for Encora X1 is QBC.

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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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