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FDA 510(k)

Enbio PRO

K-Number: K260254 · 2026-02-26

ApplicantEnbio Group AG
Decision Date2026-02-26
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Enbio PRO is a medical device manufactured by Enbio Group AG. It received FDA 510(k) clearance on 2026-02-26 under approval number K260254. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enbio PRO?

Enbio PRO is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Enbio Group AG. The 510(k) number is K260254.

When was Enbio PRO approved by the FDA?

Enbio PRO received FDA 510(k) clearance on 2026-02-26, under approval number K260254.

What company makes Enbio PRO?

Enbio PRO is manufactured by Enbio Group AG.

What is the FDA product code for Enbio PRO?

The FDA product code for Enbio PRO is FLE.

Other Devices by Enbio Group AG

K210279Enbio S K213991Enbio S

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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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