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FDA 510(k)

Evoblock, Perléon

K-Number: K243621 · 2025-04-22

ApplicantEvoden Indústria Comércio Importação E Exportação
Decision Date2025-04-22
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Evoblock, Perléon is the device name listed in this FDA 510(k) record. The listed applicant is Evoden Indústria Comércio Importação E Exportação. It received FDA 510(k) clearance on 2025-04-22 under 510(k) number K243621. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evoblock, Perléon?

Evoblock, Perléon is a medical device that received FDA 510(k) clearance on 2025-04-22. The listed applicant is Evoden Indústria Comércio Importação E Exportação. The 510(k) number is K243621.

When did Evoblock, Perléon receive FDA 510(k) clearance?

Evoblock, Perléon received FDA 510(k) clearance on 2025-04-22, under 510(k) number K243621.

Who is the listed applicant for Evoblock, Perléon?

The FDA 510(k) record lists Evoden Indústria Comércio Importação E Exportação as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evoblock, Perléon?

The FDA product code for Evoblock, Perléon is EBG.

Related Devices (Code: EBG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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