{"id":"54c690eb-ae93-484b-872f-88de21a13fcd","slug":"restore-robotics-fda-510k-k252926-2026-03","kind":"regulatory_action","headline":"Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments","summary":"Restore Robotics announced FDA 510(k) clearances (K252926) for remanufacturing two additional da Vinci Xi robotic surgical instruments: the Permanent Cautery Hook and Permanent Cautery Spatula. The company now holds four FDA clearances for Intuitive Surgical da Vinci instruments. Intuitive Surgical has granted contractual approval for Restore Robotics to remanufacture any EndoWrist instrument covered by FDA 510(k) clearance.","occurredAt":"2026-03-31T12:00:00.000Z","reviewStatus":"reviewed","modelId":null,"deploymentId":null,"companyId":"e65b91a5-9904-44f0-aec2-89660734c07c","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":"2026-08-18T03:58:28.222Z","updatedAt":"2026-08-18T15:10:30.545Z","model":null,"deployment":null,"company":{"id":"e65b91a5-9904-44f0-aec2-89660734c07c","name":"Restore Robotics","slug":"restore-robotics","description":"Restore Robotics is a medical device company that remanufactures Intuitive Surgical da Vinci Xi robotic surgical instruments, providing FDA-cleared lower-cost alternatives to OEM instruments through its [Remanufactured da Vinci Xi EndoWrist Instruments](/models/restore-robotics-remanufactured-endowrist). Based in Panama City Beach, Florida with a remanufacturing facility in Henderson, Nevada, the company holds multiple FDA 510(k) clearances and works with over 300 U.S. hospitals through its distribution partnership with Encore Medical Device Repair. Intuitive Surgical has granted contractual approval for Restore Robotics to remanufacture any EndoWrist instrument covered by an FDA 510(k) clearance.","status":null,"founded":null,"hq":"Panama City Beach, Florida, USA (remanufacturing facility: Henderson, Nevada)","hqLat":null,"hqLng":null,"hqGeocodedAt":null,"hqAddress":null,"hqPrecision":null,"website":"https://www.restorerobotics.com","fundingTotal":null,"type":null,"reviewStatus":"reviewed","lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.prnewswire.com/news-releases/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments-302729165.html","title":"Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi Robotic Instruments","sourceName":"PR Newswire","publishedAt":"2026-03-31"},{"url":"https://www.medtechdive.com/news/restore-robotics-fda-510k-clearance-remanufacture-intuitive-surgical-da-vinci-instruments/816611/","title":"Restore Robotics cleared to remanufacture 2 more da Vinci Xi instruments","sourceName":"MedTech Dive","publishedAt":"2026-04-01"},{"url":"https://www.prnewswire.com/news-releases/restore-robotics-surpasses-300-hospitals-in-robotic-instrument-recycling-and-remanufacturing-program-302583572.html","title":"Restore Robotics Surpasses 300 Hospitals in Robotic Instrument Recycling and Remanufacturing Program","sourceName":"PR Newswire","publishedAt":"2025-10-14"}],"keyFacts":[{"label":"Product","value":"Remanufactured da Vinci Xi EndoWrist robotic surgical instruments"},{"label":"FDA clearances","value":"4 x 510(k) clearances for da Vinci Xi instruments (as of March 2026)"},{"label":"CEO","value":"Clif Parker"},{"label":"Model","value":"Remanufacturing — FDA-cleared alternatives to OEM da Vinci instruments"},{"label":"Intuitive Surgical approval","value":"Contractual approval granted by Intuitive Surgical for EndoWrist remanufacturing"},{"label":"Category","value":"Surgical robotics — instrument remanufacturing"},{"label":"COO","value":"Kevin May"},{"label":"Distribution partner","value":"Encore Medical Device Repair (Master Distributor)"},{"label":"Hospitals served","value":"300+ U.S. hospitals and surgery centers (as of Oct 2025)"},{"label":"HQ","value":"Panama City Beach, Florida; remanufacturing facility in Henderson, Nevada"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-08-18T03:57:58.849Z","updatedAt":"2026-08-18T15:10:31.322Z"},"derived":{"status":"active"},"sources":[{"id":"6f843059-7807-4f10-af38-dadd9b28d18c","incidentId":"54c690eb-ae93-484b-872f-88de21a13fcd","url":"https://www.medtechdive.com/news/restore-robotics-fda-510k-clearance-remanufacture-intuitive-surgical-da-vinci-instruments/816611/","label":"MedTech Dive","publishedAt":null,"notes":null,"title":null,"sourceName":"MedTech Dive","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-18T03:58:28.222Z","updatedAt":"2026-08-18T03:58:28.222Z"},{"id":"9770f912-a5ac-4ad7-b120-526670d09b8c","incidentId":"54c690eb-ae93-484b-872f-88de21a13fcd","url":"https://www.prnewswire.com/news-releases/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments-302729165.html","label":"PR Newswire","publishedAt":null,"notes":null,"title":null,"sourceName":"PR Newswire","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-18T03:58:28.222Z","updatedAt":"2026-08-18T03:58:28.222Z"}],"responses":[],"statusEvents":[{"id":"2cd1950f-c8d5-48cd-9657-833fe3c46cad","incidentId":"54c690eb-ae93-484b-872f-88de21a13fcd","status":"active","reason":null,"source":"agent:recon","effectiveAt":"2026-08-18T03:58:29.392Z","createdAt":"2026-08-18T03:58:29.392Z"}],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/restore-robotics-fda-510k-k252926-2026-03","url":"https://registry.deploy.report/incidents/restore-robotics-fda-510k-k252926-2026-03","headline":"Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments","description":"Restore Robotics announced FDA 510(k) clearances (K252926) for remanufacturing two additional da Vinci Xi robotic surgical instruments: the Permanent Cautery Hook and Permanent Cautery Spatula. The company now holds four FDA clearances for Intuitive Surgical da Vinci instruments. Intuitive Surgical has granted contractual approval for Restore Robotics to remanufacture any EndoWrist instrument covered by FDA 510(k) clearance.","identifier":"54c690eb-ae93-484b-872f-88de21a13fcd","datePublished":"2026-03-31T12:00:00.000Z","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":["secondary-trade-publication"]}}}