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Incident · Regulatory action

Medtronic Hugo surgical robot earns FDA clearance for additional indication

FDA's K253984 record documents clearance for Medtronic's Instrument Exit Point software, an adjunct visualization feature for Hugo RAS instruments that indicates when instruments leave the endoscopic field of view (FDA K253984).

Occurred 2026-07-01 · Hugo RAS at Dublin, Ireland · Medtronic · Dublin, Ireland · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (3)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253984.pdf · 2026-06-04
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253984 · 2026-06-04
  3. https://finance.yahoo.com/news/medtronic-hugo-surgical-robot-earns-102759168.html

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in Medtronic Hugo surgical robot earns FDA clearance for additional indication?
FDA's K253984 record documents clearance for Medtronic's Instrument Exit Point software, an adjunct visualization feature for Hugo RAS instruments that indicates when instruments leave the endoscopic field of view ([FDA K253984](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253984.pdf)).
When did this incident occur?
The incident is recorded as occurring on July 1, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Medtronic Hugo surgical robot earns FDA clearance for additional indication?
Hugo RAS by Medtronic is the recorded robot involved in this incident at Dublin, Ireland.
Has anyone responded to Medtronic Hugo surgical robot earns FDA clearance for additional indication?
No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.
What is the current status of Medtronic Hugo surgical robot earns FDA clearance for additional indication?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (2 primary) · last reviewed 2026-09-29

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-09-29

Sources by quality tier

2
primary-fda-database
FDA database
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for Medtronic Hugo surgical robot earns FDA clearance for additional indication.

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Canonical ID 1a9c293e-eb71-4276-b38e-8252fac2dbba