Evoblock, Perléon
K-Number: K243621 · 2025-04-22
Decision Date2025-04-22
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Evoblock, Perléon is a medical device manufactured by Evoden Indústria Comércio Importação E Exportação. It received FDA 510(k) clearance on 2025-04-22 under approval 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. It is manufactured by Evoden Indústria Comércio Importação E Exportação. The 510(k) number is K243621.
When was Evoblock, Perléon approved by the FDA?
Evoblock, Perléon received FDA 510(k) clearance on 2025-04-22, under approval number K243621.
What company makes Evoblock, Perléon?
Evoblock, Perléon is manufactured by Evoden Indústria Comércio Importação E Exportação.
What is the FDA product code for Evoblock, Perléon?
The FDA product code for Evoblock, Perléon is EBG.
Related Devices (Code: EBG)
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.