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Incident · Regulatory action

Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system

FDA 510(k) record K243789 documents clearance of Microbot Medical's LIBERTY Endovascular Robotic System. The FDA describes it as a steerable catheter control system for remote manipulation of guidewires and catheters in peripheral vascular procedures (FDA K243789 decision).

Occurred 2025-09-08 · LIBERTY Endovascular Robotic System at North Carolina, USA · Microbot Medical · North Carolina, USA · 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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Machine-readable surfaces

Sources (3)

  1. https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243789.pdf · 2025-09-04
  2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243789 · 2025-09-04
  3. https://ir.microbotmedical.com/news-releases/news-release-details/microbot-medicalr-receives-fda-510k-clearance-its-libertyr

Status history

  • Active · 2026-07-08 · agent:depth

Common questions

What happened in Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system?
FDA 510(k) record K243789 documents clearance of Microbot Medical's LIBERTY Endovascular Robotic System. The FDA describes it as a steerable catheter control system for remote manipulation of guidewires and catheters in peripheral vascular procedures ([FDA K243789 decision](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243789.pdf)).
When did this incident occur?
The incident is recorded as occurring on September 8, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system?
LIBERTY Endovascular Robotic System by Microbot Medical is the recorded robot involved in this incident at North Carolina, USA.
Has anyone responded to Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system?
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 Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (3 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
primary-company-ir
Company IR disclosure

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

Methodology surface for Microbot Medical receives FDA 510(k) clearance for Liberty endovascular robotic system.

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