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FDA 510(k)

Atalante

K-Number: K221859 · 2022-12-29

ApplicantWandercraft SAS
Decision Date2022-12-29
Product CodePHL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Atalante is a medical device manufactured by Wandercraft SAS. It received FDA 510(k) clearance on 2022-12-29 under approval number K221859. 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?

Atalante is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Wandercraft SAS. The 510(k) number is K221859.

When was Atalante approved by the FDA?

Atalante received FDA 510(k) clearance on 2022-12-29, under approval number K221859.

What company makes Atalante?

Atalante is manufactured by Wandercraft SAS.

What is the FDA product code for Atalante?

The FDA product code for Atalante is PHL.

Other Devices by Wandercraft SAS

K232077Atalante X K250904Atalante X

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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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