FDA 510(k)

Atalante X

K-Number: K232077 · 2023-12-13

Decision Date2023-12-13

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 2023-12-13 under approval number K232077. 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 2023-12-13. It is manufactured by Wandercraft SAS. The 510(k) number is K232077.

When was Atalante X approved by the FDA?

Atalante X received FDA 510(k) clearance on 2023-12-13, under approval number K232077.

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.

Other Devices by Wandercraft SAS

K221859Atalante K250904Atalante X

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.