{"id":"1211e1a8-02ab-4c17-b7f8-4ebd6939f482","slug":"virtual-incision-mira-fda-de-novo-den230025","filingNumber":"DEN230025","filingType":"fda_de_novo","jurisdiction":"us_fda","applicantCompanyId":"3ab6cd33-66ff-4e37-acc8-e06745e8d734","filingDate":"2024-02-23T00:00:00.000Z","decisionDate":"2024-02-23T00:00:00.000Z","status":"cleared","clearanceScope":"FDA De Novo DEN230025 for Virtual Incision MIRA Surgical System. First miniaturized robotic-assisted surgery device. For colectomy procedures.","sources":[{"url":"https://www.accessdata.fda.gov/cdrh_docs/pdf23/DEN230025.pdf","title":"DEN230025 De Novo","sourceName":"FDA"}],"verificationPosture":"verified","capFlagNotes":"First miniRAS device. IDE clinical study completed.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:28:26.905Z","updatedAt":"2026-07-15T02:28:26.905Z","applicantCompany":{"id":"3ab6cd33-66ff-4e37-acc8-e06745e8d734","slug":"virtual-incision","name":"Virtual Incision"},"modelLinks":[{"id":"3b377f6c-4afb-4abe-bbf9-90b000a8ae3a","modelId":"7335dd6b-c068-4c0d-9a81-f77f53661cf9","regulatoryFilingId":"1211e1a8-02ab-4c17-b7f8-4ebd6939f482","createdAt":"2026-07-15T02:28:27.787Z","model":{"slug":"virtual-incision-mira","modelName":"MIRA"}}]}