{"id":"d4df3a39-ec40-4531-9327-935a84887890","slug":"regulatory-action-2026-01-26-intuitive-surgical","kind":"regulatory_action","headline":"Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures","summary":"Intuitive Surgical received FDA 510(k) clearance for da Vinci 5 robotic surgical system for cardiac procedures. Limited US sites to begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs.","occurredAt":"2026-01-26T12:00:00.000Z","reviewStatus":"unreviewed","modelId":null,"deploymentId":null,"companyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"minor","rootCauseCategory":null,"rootCauseDetail":null,"affectedUnitsCount":null,"affectedUnitsBasis":null,"remediationStatus":null,"regulatoryAction":"other","regulatoryBody":"FDA","propertyDamageEstimateUsd":null,"damageEstimateBasis":null,"bodilyInjurySeverity":null,"fatalityCount":null,"lossCostClass":null,"sourceQualityTier":null,"createdAt":"2026-07-03T03:55:35.988Z","updatedAt":"2026-07-03T03:55:35.988Z","model":null,"deployment":null,"company":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","name":"Intuitive Surgical","slug":"intuitive-surgical","description":"Dominant surgical-robotics maker (NASDAQ: ISRG; founded 1995, Sunnyvale CA) of the [da Vinci](/models/intuitive-da-vinci) teleoperated surgical robots and the Ion robotic bronchoscopy system; 11,000+ da Vinci installed worldwide.","status":"public (NASDAQ: ISRG)","founded":1995,"hq":"Sunnyvale, California, USA","fundingTotal":null,"type":"both","reviewStatus":"reviewed","sources":[{"url":"https://www.sec.gov/Archives/edgar/data/0001035267/000103526726000032/isrg-20260331.htm","title":"Intuitive Form 10-Q (Q1 2026): 11,395 da Vinci installed (1,464 da Vinci 5); 1,041 Ion","sourceName":"SEC EDGAR"},{"url":"https://www.sec.gov/Archives/edgar/data/1035267/000103526726000029/q126ex-991earningsrelease.htm","title":"Intuitive Q1 2026 earnings (procedures +17%; 431 da Vinci placed; revenue $2.77B)","sourceName":"SEC EDGAR"},{"url":"https://www.globenewswire.com/news-release/2024/03/14/2846718/7637/en/Intuitive-Announces-FDA-Clearance-of-Fifth-Generation-Robotic-System-da-Vinci-5.html","title":"Intuitive: FDA clearance of da Vinci 5 (510(k), Mar 14 2024; Force Feedback)","sourceName":"Intuitive (GlobeNewswire)"},{"url":"https://www.therobotreport.com/intuitive-demos-4000-mile-telesurgery-with-da-vinci-5-surgical-robot/","title":"Intuitive demos 4,000-mile telesurgery (investigational, in development)","sourceName":"The Robot Report"}],"keyFacts":[{"label":"Installed base","value":"11,395 da Vinci (1,464 da Vinci 5) + 1,041 Ion (SEC 10-Q, Q1 2026)."},{"label":"Gating events","value":"da Vinci 5 FDA-cleared Mar 14 2024; Ion FDA-cleared Feb 2019."},{"label":"Stock listing","value":"NASDAQ: ISRG"},{"label":"Market position","value":"Dominant surgical-robotics maker"},{"label":"da Vinci product type","value":"Teleoperated surgical robot"},{"label":"Ion product type","value":"Robotic bronchoscopy system"}],"aliases":["Intuitive","ISRG","da Vinci"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-06-03T20:11:59.344Z","updatedAt":"2026-06-28T13:52:14.998Z"},"derived":{"status":"active"},"sources":[{"id":"e46ae5a4-a894-48d9-9e4e-f2985cbbd1d2","incidentId":"d4df3a39-ec40-4531-9327-935a84887890","url":"https://www.massdevice.com/intuitive-fda-510k-clearances-cardiac-procedures-da-vinci-5/","label":null,"publishedAt":null,"notes":null,"title":"Intuitive wins FDA clearances for cardiac procedures on da Vinci 5","sourceName":"MassDevice","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T03:55:36.140Z","updatedAt":"2026-07-03T03:55:36.140Z"}],"responses":[],"statusEvents":[{"id":"685feb14-6eac-4f4b-a842-142eb85489ce","incidentId":"d4df3a39-ec40-4531-9327-935a84887890","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T03:55:36.295Z","createdAt":"2026-07-03T03:55:36.296Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-01-26-intuitive-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2026-01-26-intuitive-surgical","headline":"Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures","description":"Intuitive Surgical received FDA 510(k) clearance for da Vinci 5 robotic surgical system for cardiac procedures. Limited US sites to begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs.","identifier":"d4df3a39-ec40-4531-9327-935a84887890","datePublished":"2026-01-26T12:00:00.000Z","articleSection":"regulatory action","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"unreviewed","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":1,"primary_source_types":[]}}}