{"id":"c15509a8-2033-4288-9595-72803331b8e2","slug":"fda-510k-jnj-ottava-surgical-robot-2026-07","kind":"regulatory_action","headline":"FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries","summary":"The FDA authorized Johnson & Johnson's Ottava Robotic Surgical System for multiple soft tissue surgeries including gastric bypass, gastrectomy, cholecystectomy, and hiatal hernia repair. The table-integrated four-arm robot competes with Intuitive Surgical's da Vinci and Medtronic's Hugo. J&J plans a phased commercial launch with select U.S. customers.","occurredAt":"2026-07-22T12:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"766676f2-56d0-4910-81dc-03703d6c9c40","aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","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,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-27T14:05:31.784Z","updatedAt":"2026-08-09T05:24:01.599Z","model":null,"deployment":null,"company":{"id":"766676f2-56d0-4910-81dc-03703d6c9c40","name":"Johnson & Johnson","slug":"johnson-and-johnson","description":"Johnson & Johnson (NYSE: JNJ) is a global healthcare and pharmaceutical company with a surgical robotics division that develops the MONARCH platform for bronchoscopic procedures and the OTTAVA surgical robotics system. The company's robotics portfolio spans robotic-assisted surgery, digital surgery, and minimally invasive interventions.","status":"public (NYSE: JNJ)","founded":1886,"hq":"New Brunswick, New Jersey, USA","hqLat":40.4936119,"hqLng":-74.4436416,"hqGeocodedAt":"2026-08-05T14:35:14.025Z","hqAddress":null,"hqPrecision":null,"website":"jnj.com","fundingTotal":null,"type":"both","reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-ottava-robotic-surgical-system-to-the-u-s-food-and-drug-administration","title":"J&J submits Ottava to FDA (De Novo, Jan 7 2026; 'not authorized to be marketed')","sourceName":"Johnson & Johnson (official)"},{"url":"https://www.medtechdive.com/news/jnj-layoffs-auris-california-robotic/644544/","title":"J&J robotics layoffs + Ottava delays (history/context)","sourceName":"MedTech Dive"},{"url":"https://www.fiercebiotech.com/medtech/jj-to-take-over-verb-surgical-its-robotics-venture-verily","title":"J&J takes over Verb Surgical (Ottava lineage)","sourceName":"FierceBiotech"}],"keyFacts":[{"label":"Product","value":"MONATCH bronchoscopic robot, OTTAVA surgical robotics"},{"label":"Status","value":"Pre-market: FDA De Novo submitted Jan 7 2026; NOT cleared; zero installed base."},{"label":"Stock listing","value":"NYSE: JNJ"},{"label":"Developing division","value":"MedTech/Ethicon"},{"label":"Company type","value":"Global healthcare company"},{"label":"Revenue","value":"\\8B (2025, NYSE: JNJ)"}],"aliases":["J&J","JNJ","J&J MedTech","Ethicon"],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":"JNJ","stockExchange":"NYSE","secCik":"0000200406","revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-06-03T20:12:18.092Z","updatedAt":"2026-08-05T14:44:06.770Z"},"derived":{"status":"active"},"sources":[{"id":"801112da-0ffb-4191-b988-6b45c5d2c2a2","incidentId":"c15509a8-2033-4288-9595-72803331b8e2","url":"https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-market-authorization-in-the-u-s-for-its-ottava-robotic-surgical-system","label":"Johnson & Johnson","publishedAt":"2026-07-22T00:00:00.000Z","notes":null,"title":null,"sourceName":"Johnson & Johnson","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-27T14:05:31.784Z","updatedAt":"2026-07-27T14:05:31.784Z"},{"id":"4d6a5628-1993-4eff-a4dd-ba3043c86ccb","incidentId":"c15509a8-2033-4288-9595-72803331b8e2","url":"https://www.fiercebiotech.com/medtech/fda-clears-johnson-johnsons-surgical-robot-next-era-surgery","label":"Fierce Biotech","publishedAt":"2026-07-23T00:00:00.000Z","notes":null,"title":null,"sourceName":"Fierce Biotech","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-27T14:05:31.784Z","updatedAt":"2026-07-27T14:05:31.784Z"}],"responses":[],"statusEvents":[{"id":"f707e225-dd1f-407c-be3c-7f16b71a0e2f","incidentId":"c15509a8-2033-4288-9595-72803331b8e2","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-07-27T14:05:32.919Z","createdAt":"2026-07-27T14:05:32.919Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/fda-510k-jnj-ottava-surgical-robot-2026-07","url":"https://registry.deploy.report/incidents/fda-510k-jnj-ottava-surgical-robot-2026-07","headline":"FDA clears Johnson & Johnson Ottava robotic surgical system for soft tissue surgeries","description":"The FDA authorized Johnson & Johnson's Ottava Robotic Surgical System for multiple soft tissue surgeries including gastric bypass, gastrectomy, cholecystectomy, and hiatal hernia repair. The table-integrated four-arm robot competes with Intuitive Surgical's da Vinci and Medtronic's Hugo. J&J plans a phased commercial launch with select U.S. customers.","identifier":"c15509a8-2033-4288-9595-72803331b8e2","datePublished":"2026-07-22T12:00:00.000Z","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":"verified","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":2,"primary_source_types":[]}}}