Atalante X
K-Number: K250904 · 2025-10-24
ApplicantWandercraft SAS
Decision Date2025-10-24
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Atalante X is a medical device manufactured by Wandercraft SAS. It received FDA 510(k) clearance on 2025-10-24 under approval number K250904. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atalante X?
Atalante X is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Wandercraft SAS. The 510(k) number is K250904.
When was Atalante X approved by the FDA?
Atalante X received FDA 510(k) clearance on 2025-10-24, under approval number K250904.
What company makes Atalante X?
Atalante X is manufactured by Wandercraft SAS.
What is the FDA product code for Atalante X?
The FDA product code for Atalante X is PHL.
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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.