Regulatory filing

fda_de_novo (us_fda)

FDA De Novo clearance for Distalmotion Dexter surgical robot (Oct 2024). CE Mark also obtained (2020).

fda de novo · cleared · decided 2024-10-01

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Key facts

Jurisdiction: us_fda
Filing type: fda de novo
Status: cleared
Filing date: 2024-10-01
Decision date: 2024-10-01
Verification posture: verified

Applicant

Covered models (1)

Dexter

Sources (1)

https://www.distalmotion.com/

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Identity

b1e850db-7cd3-4a59-9b2b-44dc202755cd