GrandioSO Unlimited
K-Number: K251239 · 2025-05-21
ApplicantVoco GmbH
Decision Date2025-05-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GrandioSO Unlimited is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2025-05-21 under approval number K251239. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GrandioSO Unlimited?
GrandioSO Unlimited is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Voco GmbH. The 510(k) number is K251239.
When was GrandioSO Unlimited approved by the FDA?
GrandioSO Unlimited received FDA 510(k) clearance on 2025-05-21, under approval number K251239.
What company makes GrandioSO Unlimited?
GrandioSO Unlimited is manufactured by Voco GmbH.
What is the FDA product code for GrandioSO Unlimited?
The FDA product code for GrandioSO Unlimited is EBF.
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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.