{"id":"ef5b58b5-1e8f-40cf-9bfe-7aa53e51a2de","slug":"fda-510k-senhance-2017","filingNumber":"K171120","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","filingDate":"2017-04-14T12:00:00.000Z","decisionDate":"2017-10-13T12:00:00.000Z","status":"cleared","clearanceScope":"Foundational US FDA 510(k) clearance of the Senhance Surgical Robotic System; filed by TransEnterix, Inc. (later renamed Asensus Surgical). (The earlier De Novo DEN160056 could not be corroborated to a primary record - honest-absence.)","sources":[{"url":"https://api.fda.gov/device/510k.json?search=k_number:K171120","title":"FDA 510(k) K171120","sourceName":"openFDA (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-05T19:02:09.520Z","updatedAt":"2026-06-05T19:02:09.520Z","applicantCompany":{"id":"a3a097cb-a5db-4ffd-b421-5eb14335dbcf","slug":"asensus-surgical","name":"Asensus Surgical"},"modelLinks":[{"id":"a07409d7-e49b-4f76-af8b-3ac9a70dc4f4","modelId":"abadf566-b528-4b44-be3e-418ca078e920","regulatoryFilingId":"ef5b58b5-1e8f-40cf-9bfe-7aa53e51a2de","createdAt":"2026-06-05T19:02:09.601Z","model":{"slug":"asensus-senhance","modelName":"Senhance"}}]}