{"id":"e105e9f9-dcda-4d65-9e33-0c835bb43138","slug":"fda-medtronic-hugo-clearance-2025","filingNumber":"K250725","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"5ed6adff-c714-4880-bb1e-62af35017f4f","filingDate":"2025-03-10T12:00:00.000Z","decisionDate":"2025-12-03T12:00:00.000Z","status":"granted","clearanceScope":"FDA authorization for the Medtronic Hugo RAS system (US urologic indication) following its IDE pivotal trial; reported late 2025.","sources":[{"url":"https://www.medtronic.com","title":"Medtronic Hugo RAS US authorization (reported 2025)","sourceName":"Medtronic (official)"}],"verificationPosture":"reported","capFlagNotes":"Cleared via traditional 510(k) K250725 (applicant Covidien LLC); filing_type corrected from fda_de_novo to fda_510k.","relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:17:19.927Z","updatedAt":"2026-06-05T15:35:51.377Z","applicantCompany":{"id":"5ed6adff-c714-4880-bb1e-62af35017f4f","slug":"medtronic","name":"Medtronic"},"modelLinks":[{"id":"921383ff-0c07-4b21-b56a-209cdeaf05d2","modelId":"3e170eb2-145b-41a2-88d0-8ff93a5f4e78","regulatoryFilingId":"e105e9f9-dcda-4d65-9e33-0c835bb43138","createdAt":"2026-06-04T23:17:20.085Z","model":{"slug":"medtronic-hugo","modelName":"Hugo RAS"}}]}