FDA 510(k)

Atalante

K-Number: K221859 · 2022-12-29

Decision Date2022-12-29

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Atalante is the device name listed in this FDA 510(k) record. The listed applicant is Wandercraft SAS. It received FDA 510(k) clearance on 2022-12-29 under 510(k) 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. The listed applicant is Wandercraft SAS. The 510(k) number is K221859.

When did Atalante receive FDA 510(k) clearance?

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

Who is the listed applicant for Atalante?

The FDA 510(k) record lists Wandercraft SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atalante?

The FDA product code for Atalante is PHL.

Other records listing Wandercraft SAS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260381Eve K250904Atalante X K232077Atalante X

Related Devices (Code: PHL)

K260381EveWandercraft SAS K250904Atalante XWandercraft SAS K241822ReWalk® 7 Personal Exoskeleton (50-20-0005)Rewalk Robotics Ltd. Dba Lifeward K233695Medical HAL Lower Limb Type (HAL-ML)Cyberdyne, Inc.K232077Atalante XWandercraft SAS K221696ReWalk P6.0Re Walk Robotics , Ltd.

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.