# fda_de_novo (us_fda)

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

## 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

- [Medtronic](/companies/medtronic.md)

## Covered models (1)

- [Hugo RAS](/models/medtronic-hugo.md)

## Sources (1)

- [https://www.medtronic.com/](https://www.medtronic.com/)

_Canonical URL: /regulatory-filings/medtronic-hugo-fda-de-novo. HTML version: [/regulatory-filings/medtronic-hugo-fda-de-novo](/regulatory-filings/medtronic-hugo-fda-de-novo)._