{"id":"6b166e72-1d20-4f9c-b85f-5c3542df97b5","slug":"auris-monarch-fda-510k","filingNumber":null,"filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","filingDate":"2018-01-01T00:00:00.000Z","decisionDate":"2018-01-01T00:00:00.000Z","status":"cleared","clearanceScope":"FDA 510(k) clearance for Auris Health Monarch surgical robot. Second FDA clearance for urology indication.","sources":[{"url":"https://www.fiercebiotech.com/medtech/fda-crowns-monarch-surgical-robot-jjs-auris-health-urology-nod","title":"FDA crowns Monarch surgical robot","sourceName":"Fierce Biotech"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:30:38.686Z","updatedAt":"2026-07-15T02:30:38.686Z","applicantCompany":{"id":"df69ac5c-53c1-4fa6-94d2-8f377e9bf87c","slug":"auris-health","name":"Auris Health"},"modelLinks":[{"id":"9e06ed03-ca5b-476b-a804-9980e6e051df","modelId":"fec634ea-8227-4fba-8acc-695f3728a469","regulatoryFilingId":"6b166e72-1d20-4f9c-b85f-5c3542df97b5","createdAt":"2026-07-15T02:30:39.556Z","model":{"slug":"auris-health-monarch","modelName":"Monarch Platform"}}]}