> **PROPOSED: not yet in effect** · 2026-06-03
> Initial ingestion

_Regulation · Permit · proposed_

# Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties

Canonical ID: `c818a84c-6fb3-4827-8ba4-a5080c7a7df7`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** proposed
- **Effective:** 2026-06-03

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.

## Sources (1)

1. 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 · 2026-06-03

## Status history

- **proposed** · 2026-06-03 · agent-recon
    - Initial ingestion

## Common questions

### What does Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties cover?

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.

### Where does Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties apply?

Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties is recorded as a permitting requirement applying in United States on the DEPLOY registry.

### When did Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties take effect?

Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties is recorded as effective June 3, 2026 on the DEPLOY registry.

### Is Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties still in effect?

Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties is proposed but not yet in effect; subject to revision before adoption.

### What types of robots does Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties apply to?

Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties is recorded as applying to surgical on the DEPLOY registry.

### Which robot models on the DEPLOY registry fall under Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties?

8 robot models on the DEPLOY registry match the form-factor scope of Medtronic Submits 510(k) Filings to Expand Hugo Robotic Surgery System into General and Gynecologic Specialties: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.


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