{"id":"c818a84c-6fb3-4827-8ba4-a5080c7a7df7","slug":"fda-510k-medtronic-hugo-expansion","kind":"permit","headline":"Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties","summary":"Medtronic submitted 510(k) filings to expand its Hugo robotic-assisted surgery system into general and gynecologic surgical specialties in the United States, positioning it to compete with Intuitive Surgical in major robotic surgery markets.","locationId":"aa8b9c05-c836-4021-801f-59801970401e","effectiveAt":"2026-06-03T00:00:00.000Z","expiresAt":null,"reviewStatus":"unreviewed","formFactors":["surgical"],"jurisdiction":"US Federal","complianceDeadline":null,"enforcementEvents":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"createdAt":"2026-08-09T14:28:55.875Z","updatedAt":"2026-08-09T14:28:55.875Z","location":{"id":"aa8b9c05-c836-4021-801f-59801970401e","name":"United States","slug":"united-states","kind":"country","parentLocationId":null,"region":null,"lat":37.0902,"lng":-95.7129,"reviewStatus":"reviewed","aliases":["USA","US","United States of America","united-states-usa","United States"],"collisionRisk":"high","reviewNote":null,"createdAt":"2026-05-30T22:00:33.148Z","updatedAt":"2026-08-09T01:55:18.164Z"},"derived":{"status":"proposed"},"sources":[{"id":"a9098b01-bb23-47e7-b44b-ee6db7d483bb","regulationId":"c818a84c-6fb3-4827-8ba4-a5080c7a7df7","url":"https://news.medtronic.com/2026-06-03-Medtronic-submits-510-k-filings-to-expand-Hugo-TM-robotic-assisted-surgery-system-into-general-and-gynecologic-specialties-in-the-United-States","label":null,"publishedAt":"2026-06-03T00:00:00.000Z","notes":null,"title":"Medtronic submits 510(k) filings to expand Hugo robotic-assisted surgery system","sourceName":"Medtronic","mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-08-09T14:28:55.875Z","updatedAt":"2026-08-09T14:28:55.875Z"}],"statusEvents":[{"id":"045c9379-948e-439a-86ff-410fc2fd3bfe","regulationId":"c818a84c-6fb3-4827-8ba4-a5080c7a7df7","status":"proposed","reason":"Initial ingestion","source":"agent-recon","effectiveAt":"2026-06-03T00:00:00.000Z","createdAt":"2026-08-09T14:28:55.875Z"}],"jsonLd":{"@context":"https://schema.org","@type":"Legislation","@id":"https://registry.deploy.report/regulations/fda-510k-medtronic-hugo-expansion","url":"https://registry.deploy.report/regulations/fda-510k-medtronic-hugo-expansion","name":"Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties","description":"Medtronic submitted 510(k) filings to expand its Hugo robotic-assisted surgery system into general and gynecologic surgical specialties in the United States, positioning it to compete with Intuitive Surgical in major robotic surgery markets.","identifier":"c818a84c-6fb3-4827-8ba4-a5080c7a7df7","legislationDate":"2026-06-03T00:00:00.000Z","legislationApplies":{"@type":"Place","name":"United States"},"publisher":{"@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":[]}}}