{"id":"d0a1a82c-3876-4714-81b1-cfe5acee7152","slug":"regulatory-action-2026-06-15-revolve-surgical","kind":"regulatory_action","headline":"Revolve Surgical receives FDA 510(k) clearance for surgical robot platform","summary":"Revolve Surgical received FDA 510(k) clearance for its surgical robot platform. The Canada-based company develops a surgical robot for minimally invasive procedures.","occurredAt":"2026-06-15T12:00:00.000Z","reviewStatus":"reviewed","modelId":"6639d16f-4c1b-4be3-b933-425f5cf09dc4","deploymentId":"3ce806cb-e962-42db-b20a-cdcc5d3b3271","companyId":"085e5b40-c212-4c66-94f3-7e958513db2b","dataCenterId":null,"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,"oshaRecordable":null,"oshaCaseNumber":null,"rootCauseDisclosed":null,"publicDisclosureDate":null,"insuranceClaimPublic":null,"formFactor":null,"latitude":null,"longitude":null,"autonomyClass":null,"legalOutcomeClass":"unknown","createdAt":"2026-07-03T03:17:39.496Z","updatedAt":"2026-07-14T21:53:38.350Z","model":{"id":"6639d16f-4c1b-4be3-b933-425f5cf09dc4","companyId":"085e5b40-c212-4c66-94f3-7e958513db2b","modelName":"Revolve Surgical Platform","slug":"revolve-surgical-platform","description":"Canadian surgical robotics startup developing a table-mounted, zero-footprint surgical platform for minimally invasive procedures. Founded in 2019, the company received FDA 510(k) clearance in 2025 for its surgical robot system, which features reusable table-mounted arms with 5mm wristed instruments. A Y Combinator S21 alum, Revolve Surgical aims to make robotic surgery accessible to every operating room with a compact, low-cost design.","formFactor":"surgical","industryVertical":"healthcare","environment":"indoor","maturityStage":"pilot","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.massrobotics.org/revolve-surgical-wins-fda-clearance-for-surgical-robot/","title":"Revolve Surgical wins FDA clearance for surgical robot","sourceName":"MassRobotics"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"FDA 510(k)","value":"Cleared for general surgery"},{"label":"CEO","value":"Peter Francis"},{"label":"Co-founders","value":"Alex Gordon, Matthew Kang"},{"label":"FDA clearance","value":"510(k) cleared October 2025"},{"label":"YC batch","value":"S21"}],"createdAt":"2026-07-02T17:11:32.940Z","updatedAt":"2026-07-12T04:24:54.291Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null},"deployment":{"id":"3ce806cb-e962-42db-b20a-cdcc5d3b3271","modelId":"6639d16f-4c1b-4be3-b933-425f5cf09dc4","versionId":null,"locationId":"61a2ffb9-8da6-48c9-9793-565d5d4615c1","operatorId":"085e5b40-c212-4c66-94f3-7e958513db2b","ownerId":null,"slug":"revolve-surgical-platform-toronto-ontario-canada","status":"announced","firstSeen":"2025-11-01T00:00:00.000Z","statusChangeReason":null,"contractType":null,"pilotOutcome":null,"endedAt":null,"unitsOnSite":null,"tasksPerformed":["surgical_assistance"],"shiftStructure":null,"hoursPerDay":8,"siteType":"hospital","operatorConfirmed":null,"humanSupervisionOnsite":null,"locationPrecisionTier":"city_centroid","deploymentScale":"small_2_10","siteEnvironment":"indoor","operatorType":null,"sourceQualityTier":2,"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.linkedin.com/posts/revolve-surgical_revolve-surgical-wins-fda-clearance-for-surgical-activity-7439717588600946689-Uk_k","name":"LinkedIn / Revolve Surgical","title":"Revolve Surgical Receives FDA Clearance for AI-Assisted Surgery"}],"notes":"Revolve Surgical partnered with Unity Health Toronto (St. Michael's Hospital) as its first clinical implementation site. FDA clearance announced November 2025. The Revolve Surgical website lists St. Michael's Hospital as a partner. No confirmed clinical procedures yet.","keyFacts":[],"reviewNote":null,"exposureHours":null,"deploymentMilesEstimate":null,"exposureBasis":null,"customerSegment":"healthcare","scaleTier":"pilot_lt10","contractValueUsd":null,"contractValueBasis":null,"customerCompanyId":null,"customerExternalName":null,"createdAt":"2026-08-08T22:33:30.054Z","updatedAt":"2026-08-21T14:21:49.299Z"},"company":{"id":"085e5b40-c212-4c66-94f3-7e958513db2b","name":"Revolve Surgical","slug":"revolve-surgical","description":"Canadian surgical robotics startup developing a table-mounted, zero-footprint surgical platform for minimally invasive procedures. Founded in 2019, the company received FDA 510(k) clearance in 2025 for its surgical robot system, which features reusable table-mounted arms with 5mm wristed instruments. 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