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FDA 510(k)

EnDrive (EnDriveUS)

K-Number: K243692 · 2025-08-22

ApplicantAdvanced Technology Research (A.T.R.) S.R.L.
Decision Date2025-08-22
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EnDrive (EnDriveUS) is a medical device manufactured by Advanced Technology Research (A.T.R.) S.R.L.. It received FDA 510(k) clearance on 2025-08-22 under approval number K243692. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EnDrive (EnDriveUS)?

EnDrive (EnDriveUS) is a medical device that received FDA 510(k) clearance on 2025-08-22. It is manufactured by Advanced Technology Research (A.T.R.) S.R.L.. The 510(k) number is K243692.

When was EnDrive (EnDriveUS) approved by the FDA?

EnDrive (EnDriveUS) received FDA 510(k) clearance on 2025-08-22, under approval number K243692.

What company makes EnDrive (EnDriveUS)?

EnDrive (EnDriveUS) is manufactured by Advanced Technology Research (A.T.R.) S.R.L..

What is the FDA product code for EnDrive (EnDriveUS)?

The FDA product code for EnDrive (EnDriveUS) is EKX.

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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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