FDA 510(k)

Eve

K-Number: K260381 · 2026-08-03

Decision Date2026-08-03

Product CodePHL

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

Eve is the device name listed in this FDA 510(k) record. The listed applicant is Wandercraft SAS. It received FDA 510(k) clearance on 2026-08-03 under 510(k) number K260381. 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 Eve?

Eve is a medical device that received FDA 510(k) clearance on 2026-08-03. The listed applicant is Wandercraft SAS. The 510(k) number is K260381.

When did Eve receive FDA 510(k) clearance?

Eve received FDA 510(k) clearance on 2026-08-03, under 510(k) number K260381.

Who is the listed applicant for Eve?

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 Eve?

The FDA product code for Eve 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.

K250904Atalante X K232077Atalante X K221859Atalante

Related Devices (Code: PHL)

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.K221859AtalanteWandercraft SAS

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.