{"id":"d04f8a5a-914a-4df3-affc-c71e062d3afc","slug":"fda-510k-intuitive-ion-2019","filingNumber":"K182188","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","filingDate":"2018-08-13T12:00:00.000Z","decisionDate":"2019-02-14T12:00:00.000Z","status":"cleared","clearanceScope":"Foundational FDA 510(k) clearance of the Intuitive Ion Endoluminal System (robotic-assisted bronchoscopy for peripheral lung biopsy; clearance also covered the Flexision biopsy needle).","sources":[{"url":"https://api.fda.gov/device/510k.json?search=k_number:K182188","title":"FDA 510(k) K182188","sourceName":"openFDA (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-05T19:02:08.250Z","updatedAt":"2026-06-05T19:02:08.250Z","applicantCompany":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","slug":"intuitive-surgical","name":"Intuitive Surgical"},"modelLinks":[{"id":"9ebeb93e-35d1-4085-a857-c86b0eda25ab","modelId":"0e2f5d6f-8ce6-4726-9301-d438ecf732bc","regulatoryFilingId":"d04f8a5a-914a-4df3-affc-c71e062d3afc","createdAt":"2026-06-05T19:02:08.433Z","model":{"slug":"intuitive-ion","modelName":"Ion Endoluminal System"}}]}