Regulatory filing
K250725 (us_fda)
FDA authorization for the Medtronic Hugo RAS system (US urologic indication) following its IDE pivotal trial; reported late 2025.
fda 510k · granted · decided 2025-12-03
Machine-readable surfaces
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- Revision history: /regulatory-filings/fda-medtronic-hugo-clearance-2025/history
- Data documentation: /data
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
Covered models (1)
Sources (1)
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Identity
e105e9f9-dcda-4d65-9e33-0c835bb43138