{"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":"unreviewed","modelId":null,"deploymentId":null,"companyId":"085e5b40-c212-4c66-94f3-7e958513db2b","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":"2026-07-03T03:17:39.496Z","updatedAt":"2026-07-03T03:17:39.496Z","model":null,"deployment":null,"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. A Y Combinator S21 alum, Revolve Surgical aims to make robotic surgery accessible to every operating room with a compact, low-cost design.","status":null,"founded":2019,"hq":"Canada","fundingTotal":null,"type":"hardware","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"}],"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"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"createdAt":"2026-07-02T17:11:32.780Z","updatedAt":"2026-07-02T17:29:41.418Z"},"derived":{"status":"active"},"sources":[{"id":"a91d5c1f-2772-4170-b32f-1264193c3948","incidentId":"d0a1a82c-3876-4714-81b1-cfe5acee7152","url":"https://www.massrobotics.org/revolve-surgical-wins-fda-clearance-for-surgical-robot/","label":null,"publishedAt":null,"notes":null,"title":"Revolve Surgical wins FDA clearance for surgical robot","sourceName":"MassRobotics","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-07-03T03:17:39.651Z","updatedAt":"2026-07-03T03:17:39.651Z"}],"responses":[],"statusEvents":[{"id":"0256c689-6d1a-4911-aaf9-f7e4a7e9e5ed","incidentId":"d0a1a82c-3876-4714-81b1-cfe5acee7152","status":"active","reason":null,"source":"agent:depth","effectiveAt":"2026-07-03T03:17:39.810Z","createdAt":"2026-07-03T03:17:39.811Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-revolve-surgical","url":"https://registry.deploy.report/incidents/regulatory-action-2026-06-15-revolve-surgical","headline":"Revolve Surgical receives FDA 510(k) clearance for surgical robot platform","description":"Revolve Surgical received FDA 510(k) clearance for its surgical robot platform. The Canada-based company develops a surgical robot for minimally invasive procedures.","identifier":"d0a1a82c-3876-4714-81b1-cfe5acee7152","datePublished":"2026-06-15T12:00:00.000Z","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":[]}}}