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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 the device name listed in this FDA 510(k) record. The listed applicant is Encora, Inc.. It received FDA 510(k) clearance on 2026-02-05 under 510(k) 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. The listed applicant is Encora, Inc.. The 510(k) number is K251517.

When did Encora X1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Encora X1?

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

What is the FDA product code for Encora X1?

The FDA product code for Encora X1 is QBC.

Related Devices (Code: 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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