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FDA 510(k)

LIBERTY Endovascular Robotic System (LIBERTYOS)

K-Number: K243789 · 2025-09-04

ApplicantMicrobot Medical , Ltd.
Decision Date2025-09-04
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIBERTY Endovascular Robotic System (LIBERTYOS) is a medical device manufactured by Microbot Medical , Ltd.. It received FDA 510(k) clearance on 2025-09-04 under approval number K243789. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIBERTY Endovascular Robotic System (LIBERTYOS)?

LIBERTY Endovascular Robotic System (LIBERTYOS) is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Microbot Medical , Ltd.. The 510(k) number is K243789.

When was LIBERTY Endovascular Robotic System (LIBERTYOS) approved by the FDA?

LIBERTY Endovascular Robotic System (LIBERTYOS) received FDA 510(k) clearance on 2025-09-04, under approval number K243789.

What company makes LIBERTY Endovascular Robotic System (LIBERTYOS)?

LIBERTY Endovascular Robotic System (LIBERTYOS) is manufactured by Microbot Medical , Ltd..

What is the FDA product code for LIBERTY Endovascular Robotic System (LIBERTYOS)?

The FDA product code for LIBERTY Endovascular Robotic System (LIBERTYOS) is DXX.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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