Regulatory filing

fda_de_novo (us_fda)

FDA De Novo / urology clearance for Medtronic Hugo RAS (Dec 2025). IDE pivotal trial ongoing.

fda de novo · cleared · decided 2025-12-01

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Key facts

Jurisdiction: us_fda
Filing type: fda de novo
Status: cleared
Filing date: 2025-12-01
Decision date: 2025-12-01
Verification posture: verified

Applicant

Covered models (1)

Hugo RAS

Sources (1)

https://www.medtronic.com/

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Identity

d10b6d43-af20-4a14-a278-cdfa9a0289bf