FDA 510(k)

EnDrive (EnDriveUS)

Número K: K243692 · 2025-08-22

RequerenteAdvanced Technology Research (A.T.R.) S.R.L.

Data da decisão2025-08-22

Código do produtoEKX

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the EnDrive (EnDriveUS)?

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

When did EnDrive (EnDriveUS) receive FDA 510(k) clearance?

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

Who is the listed applicant for EnDrive (EnDriveUS)?

The FDA 510(k) record lists Advanced Technology Research (A.T.R.) S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

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