# K250725 (us_fda)

FDA authorization for the Medtronic Hugo RAS system (US urologic indication) following its IDE pivotal trial; reported late 2025.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: granted
- Filing number: K250725
- Filing date: 2025-03-10
- Decision date: 2025-12-03
- Verification posture: reported
- Cap-flag notes: Cleared via traditional 510(k) K250725 (applicant Covidien LLC); filing_type corrected from fda_de_novo to fda_510k.

## Applicant

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

## Covered models (1)

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

## Sources (1)

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

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